ae Ky WE ju ae KDIGO Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation @ wolters Kluwer www.transplantjournal.comOfficial Journal of 3 April 2020 ll Volume 104 i Number 4S ‘Tho Transplantation Society & (* International Liver Transplantation Society \ Transplantation Contents Disclaimer... KDIGO Executive Committee . Work Group Membership Preface Reference Keys. KDIGO CKD Nomenclature Conversion Factors... Abbreviations and Acronyms... . KDIGO Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation... ‘Summary of Recommendation Statements... Methods for Guideline Development... Section 1: Access to Transplantation.. Section 2: Age... Section 3: Pediatric Issues........ Sait 4 Pafehicesiel Auaondincs. Section 5: Adherencé Section 6: Tobacco. Section 7: Surgical Issues including Obesity. Section 8: Diabetes. Section 9: Cause of End-Stage Kidney Disease (ESKD) Section 10: Infections. Section 1 Section 4 Section 4 Section 14: Peripheral Arterial Disease (PAD) Section 15: Neurologic Di Gastronintestinal and Liver Disease lematologic Disorders jone and Mineral Metabolism..... immunological Assessment... Section 1 Section 1 Section 1 Section 1 Acknowledgments... References..... , Appendix: Biographie and Disclosure Information, s1 s2 s3 84 sé s7 ss so sit st 822 $33 $35 836 837 $39 sat 843 s46 s47 S55 s63 s67 ses s72 873 S75 S77 79 s80 883 s84 sosOfficial Journal of April 2020 Ml Volume 104 fl Number 4S ‘olomaoral Live Traneplatation Solty Wy 4 Transplantation r Contents Table 1. Systematic review topics and screening criteria .. $24 Table 2. Hierarchy of outcomes .... ‘2 $27 Table 3. Work products for the guideline s28 Table 4, Classification of study quality .. seseenseone $29 Table 8. GRADE system for grading quality of evidence s20 Table 6. Final grade for overall quality of evidence .. $30 Table 7. Balance of benefits and harms ... $30 Table 8. KDIGO nomenclature and description for grading recommendations ... s30 Table 9. Determinants of strength of recommendation s3t Table 10. The Conference on Guideline Standardization (COGS) checklist for reporting clinical practice guidelines s3t Table 11. Recommendations for initial and follow-up sereening ef viral and nen-viral pathogens in kidney transplant candidates . S57 Table 12. Summary of routine vaccinations for kidney transplant candidates s62 Table 13. Recommendations for cancer screening in the general population and potential transplant candidates 2 2 . | Table 14. Recommended waiting times between cancer remission and kidney transplantation ..... S65 Figure 1. Search yield s28 Figure 2, Reevaluation protocol after graft loss to nonadherence ..... wee S42 Howat Hanlin teniecomskanlien Nites ammalenl candidaleasoiitl ....... BA(© 2020 Weters Kiwer DISCLAIMER SECTION I: USE OF THE CLINICAL PRACTICE GUIDELINE This Clinical Practice Guideline document is based upon systematic literature searches, last conducted in August 2017 supplemented with additional cvidence review through May 2019. It is designed to assist decision making, It is not intended to define a standard of care, and should not be interpreted as prescribing an exclusive course of management. Variations in practice will inevitably and appropriately occur when considering the needs of individual patients, available resources, and limitations unique to an institution or type of practice. Healthcare professionals using these recommendations should decide how to apply them to their own clinical practice. SECTION II: DISCLOSURE, Kidney Disease: Improving Global Outcomes (KDIGO) makes every effort to avoid any actual oF reasonably perceived conflicts of interest that may arise from an outside tclationship or a personal, professional, or business interest of a member of the Work Group. All members of the Work Group are required to complete, sign, and submit a disclosnire and attestation form showing all such relationships that might be perceived as or are actual conflicts of interest. This document is updated annually and information is adjusted accordingly. All reported information is published in its entirety atthe end of the document and is kept on file at KDIGO. ‘Capyritt © 2000 by KDIGO. AI rit ecard. Tis an opar-soosn ari dstinatad under to ts of tho Cowie (Carmens Atrxge Don Commeradt No Deaatues icanse 0 (OCBYINC-NO} where pamisable © dewria’ and nae {te werk pred prego cho. Tho werk care bo Charged nary Way e sod convene tut ofc pam” ‘inwing am KONG. Data on how to sack operas, permis fr opciones, ara ¥en about "KO)GO's pemissons pasos canbe obtahed by contacting Cane een Execive Dect a: are iene 0) Totrotuextoent ot tn nther KIGO,Tanepkriaion Suppo ner oauters conus, asta, assam0 37y lay fr any ery ander cemage to paras er pope 352 mater prods aby nazis cares, oe a soar cpacten of ry matoss, pods, snus, Bs caresnad nthe mafia hace.82 ‘Transplantation m Apri 2020 m Volume 104 m Nunber 45 vrwarearsplanjoumal.com KDIGO EXECUTIVE COMMITTEE Garabed Eknoyan, MD Norbert Lameire, MD, PhD Founding KDIGO Co-Chairs David C. Wheeler, MD, FRCP Immediate Past Co-Chair Michel Jadoul, MD KDIGO Co-Chair Mustafa Arici, MD. Tara |. Chang, MD, MS Jennifer E. Flythe, MD, MPH Masafumi Fukagawa, MD, PhD Morgan E. Grams, MD, MHS, PhD Fan Fan Hou, MD, PhD Meg J. Jardine, MBBS, PhD Markus Ketteler, MD Magdalena Madero, MD Wolfgang C. Winkelmayer, MD, MPH, ScD KDIGO Co-Chair Jolanta Malyszko, MD, PhD Ikechi G. Okpechi, MBBS, ACP, PhD Rukshana Shrott, MD, FRCPCH, PhD Laura Sola, MD Paul E, Stevens, MB, FRCP ‘Sydney C.W. Tang MBBS, MD, PhD, FRCP (LEG), FHKCR, FHKAM Mareello A. Tonelli, MD, SM, FRCPC Christina M. Wyatt, MD, MSc KDIGO Staff John Davis, Chief Executive Officer Danialle Green, Executive Director Michael Cheung, Chief Scientific Officer Malissa Thompson, Chief Operating Officer Tanya Groen, Events Director Copyright © 2020 Wolters Kiuwer Health, Inc. Unauthorized reproduction of this article is prohibited.(© 2020 Weters Kiwer WORK GROUP MEMBERSHIP Work Group Co-Chairs Steven J. Chadban, BMed (hons), PhD, FAAHMS, FRAGP Royal Prince Alfred Hospital and Charles Perkins Centre, University of Sydney Sydney, Australia| Curie Ahn, MD, PhD Seoul National University Seoul, South Korea David A. Axelrod, MD, MBA, FACS. University of lowa lowa City, JA, USA Bethany J. Foster, MD, MSCE The Montreal Children's Hospital McGill University Health Centre Montreal, Canada Bertram L. Kasiske, MD, FAC Hennepin County Medical Genter Minneapoiis, MN, USA Vijay Kher, MD, DM, FAMS, FROPE, FIMAS. Medanta Kidney and Urology Institute Haryana, India Deepali Kumar, MD, MSc, FRCPC, FAST University Health Network University of Toronto, Toronto, Canada Rainer Oberbauer, MD, PhD Maical University of Vienna Vienna, Austria Gregory A. Knoll, MD, MSc, FRCPC Department of Medicine ‘The Ottawa Hospital and Ottawa Hospital Research Institute Ottawa, Canada Jullo Pascual, MD, PhD Hospital del Mar Barcelona, Spain Helen L, Pilmore, MD, FRACP Auckland City Hospital ‘Auckland, New Zealand James R. Rodrigue, PhD, FAST Beth Israel Deaconess Medical Center Boston, MA, USA Domy L. Segey, MD, PhD Johns Hopkins University Baltimore, MD, USA Nei S. Sheerin, BSc, PhD, FROP Neweastle University Neweastle, United Kingdom Kathryn J. Tinckam, MD, MMSe, FRCPC, FAST University Health Network University of Toronto Toronto, Canada Germaine Wong, MD, PhO University of Sydney ‘Sydney, Australia Evidence Review Team Center for Evidence Synthesis in Health, Brown University School of Public Health, Providence, Ri, USA Ethan M. Balk, MD, MPH, Project Director, Evidence Review Team Director Craig E. Gordon, MD, MS, Assistant Project Director, Evidence Review Team Associate Director Amy Eariey, BS, Research Associate Valerie Roteberg, ScM, Research Associate‘84 Transplantation Ape 2020 a Volume 108 at Number aS vrwarearsplanjoumal.com PREFACE INTRODUCTION Transplantation isthe kidney replacement therapy of choice for suitable patients with end-stage kidney disease (ESKD). However, nor all patients are suitable candidates for transplantation, and suitability is often determined by the perceived risks of transplantation relative o the risks of not receiving a transplant. Estimation of risk is therefore a key part of the transplant candidate evaluation. Should a decision to proceed to transplantation be made, consideration of how to minimize risks and maximize the chances of a suecessful outcome are additional aspects of the candidate evaluation process. This guideline systematically examines current evidence concerning the risks of transplantation associated with specific conditions and provides recommendations as to how inicians may wish to deal with specific risk factors in isolation. In practice, patients are frequently complex and exhibit multiple risk factors for poor transplant outcomes. Ultimately the clinician will be required to synthesize the toral risk burden that each candidate presents in deciding on suitability for teansplantation. addresses the evaluation and management of possible candidates for kidney transplantation alone, from either a deceased oF living donor. It covers the time period from the first consideration of the need for kidney replacement therapy to kidney transplant surgery. It considers adult and pediatric candidates. Education of the candidate and theie family is beyond the scope of this guidclines however, we do wish to highlight the essential role of patient education in parallel with the evaluation process, a it is required to enable shared decision making and consent regarding the decision to proceed to transplantation or not. This guideline does not address candidates for combined transplantation of a kidney and another ‘organ bur we have attempted to be as comprehensive as possible in addressing all clinically rclevant conditions that may impact transplant candidacy. However, given the breadth of conditions relevant to transplantation and the rapidly evolving nature of data in medicine, it is likely that we may have omitted some issues and in other instances will have cited data that will be superceded. Please consult Methods for Guideline Development for further details. TARGET AUDIENCE This guideline is intended for caregivers who refer and/or evaluate patients for possible kidney transplantation BACKGROUND AND PRINCIPLES UNDERPINNING THE GUIDELINE Ethics Kidney transplantation, using organs obtained from either living or deceased donors, should be conducted in accordance with the Declaration of Istanbul,! which provides clear guidelines on ethical practice in this area. Local considerations Asa global guideline, Kidney Disease: Improving Global Outcomes (KDIGO) nccessasily secks and considers all available evidence in producing guidelines which are of slobal relevance. However, the fact that the practice and outcomes of transplantation var enormously across the globe~ between continents, countries and even jurisdictions~ requires the reader to consider their local practices and outcomes in interpreting and implementing the guideline. In particular, considerations should include: 1. Superiority of transplantation over dialysis for the provision of kidney replacement therapy. Existing data clearly demonstrate that on average, transplantation achieves superior medical outcomes (ic. survival and quality of life) at lower cost as compared to dialysis and transplantation is therefore considered to be the medically desirable and economically(© 2020 Weters Kiwer dominant therapy. However, this conclusion is based upon data from high income countries with good access to both transplantation and dialysis.” This conclusion is likely to hold true for low- and middle-income countries from a medical perspective, though whether transplantation is cheaper than dialysis in this context is less certain and remains to be 2. Access to dialysis and transplantation In yome areas, acces o dialysis andor transplantation may be restricted or absent. This may be duc to the lack (or absence) of necessary infrastructure of services, cost of serviees to the patient, geographical inaccessibility, or other factors. Thus, access must be considered when interpreting these guidelines. 3. Outcomes of dialysis and transplantation. The decision to pursue transplantation in preference to dialysis for any given patient is based upon an expectation of superior outcomes following transplantation. To make this decision, knowledge of expected ‘outcomes from dialysis and transplantation, at a local level is required. For example if local transplant outcomes yield a 60% patient survival at 2 years, whereas dialysis yields 70% survival, then transplantation may not be justified for an average patient with ESKD. In the absence of local data describing the outcomes of dialysis and transplantation, the decision to transplant or not must be made by adaptation of available data to the local context. 4. Local risks involved in transplantation. Regional and geographical variation in risk is evident following transplantation and should be considered in implementing the Guideline. ‘The risk of infection after transplantation exhibits marked regional variation in type, frequency and severity. For example, the risk of post-transplant reactivation of latent tuberculosis (TB) is high among those from endemic areas, yet profoundly low among, those from temperate climates. Cancer incidence is also affected by geography, genctics and lifestyle. For example, skin cancer is a common cause of death among Caucasian kidney transplant recipients in Australia, particularly among those residents with high sun exposure, yet skin cancers are far less common and are a rare cause of death in other areas of the ‘world. Thus, local knowledge and understanding of likely risks and benefits are required to place the recommendations made within this Guideline into local context. ‘We thank the Work Group Co-Chairs, Drs. Greg Knoll and Steve Chadban, along with all the Work Group members who volunteered countless hours of their time to develop this guideline. We also thank rhe Evidence Review Team at the Brown University School of Public Health, KDIGO staff, and The Transplantation Society for their support which made this project possible. Michel Jacoul, MD Wolfgang C. Winkelmayer, MD, MPH, ScD KDIGO Co-Chairs‘86 Transplantation Ape12020 a Volume 108 at Number aS vrwarearsplanjoumal.com REFERENCE KEYS KDIGO NOMENCLATURE AND DESCRIPTION FOR GRADING GUIDELINE RECOMMENDATIONS Within each recommendation, the strength of recommendation is indicated as Level 1, Level 2, or Not Graded, and the quality of the supporting evidence is shown as A, B,C, or D. Implications Grate" Patonts ‘nets Polley Level 1 Most paople inyour situation Mast patents should receive ‘The recommentstion can be recommend" would want the recom- ‘the recommended course _evahntad as a canddate for mended couse acton of action develooing policy oa peror- and only a small proportion mane measure would not Level2 The mejor of people your —_Diferent choices willbe appro- The recommersation is ly "Wesuggest” ——_siuaionwould want te ree- priate for diferent paints. rege substantial debate and ‘ommended couse action, Each paint needs help inolement of stakeholders tut mary would not foariveatamanagement before policy canbe deter- decison eonsktont wth her mined orhis lus and preferences “Thain capt Gad usd pay ros gitar tsnn connon cesar wha Atop eet ppestn ct te est connon aap ecard ny wen, cet awl wor dina eal Ug ‘Seannandetre a grey wero np dodanbve tres unt eat treads berg rege zamena fone Presson Grade uaiy of idence Mesning A High We are confident thatthe ue effect fs close to that ofthe estate ofthe effect Be Moderate ‘The te effects Healy to cose to the estimate ofthe affect, but theres a possibity that tis substantial ferent ctw The tne effect may be substantially diferent from the estimate ofthe effect Dd Veylow ‘The sstimat of fect is vary uncertain, and often wil be far fom the truth87 CURRENT CHRONIC KIDNEY DISEASE (CKD) NOMENCLATURE USED BY KDIGO CKD is defined as abnormalities of kidney structure or function, present for > 3 months, with implications for health. CKD is classified based on Cause, GFR category (G1-G5), and Albuminuria category (A1-A3), abbreviated as CGA. Prognosis of CKD by GFR and albuminuria category? Persistent albuminuria categories Description and range at 2 a Prognosis of CKD by GFR and albuminuria categories: womalte [ wedertay | severty KDIGO 2012 tncreasea | Ineveosed | Inerensed <20mo | 200mg | >200mo9 300 ‘ACR (approximate equvalen (mgm) (oa) Toms <3 <30 Normal o mildly inzeased a0 30-300 Moderately creased >20 > 200 Severe inzeased™ CR, uni cet aA, akan xan ay CD, cron rey ese “Pele young at oe “feta eto yom (unin crt aly > 2000928 are > 200m > 2a‘88 Transplantation a Ape 2020 a Volume 108 at Number aS vrwarearsplanjoumal.com CONVERSION FACTORS OF CONVENTIONAL UNITS TO SI UNITS Conventional Unit Conversion Factor ‘stunt Greainine ng Bad nal ie: Conenonl in nacre(© 2020 Weters Kiwer Acc ADPKD AGREE CKD G4, CKD G5 CKD-MBD cMv, cocs cPRA cst cr cvD DAA bpp DM ‘Copyright: ABBREVIATIONS AND ACRONYMS American College of Cardiology ‘Autosomal dominant polycystic kidney discase Appraisal of Guidelines for Research and Evaluation, ‘American Heart Association Atypical hemolytic uremic syndrome ‘Anti-ncutrophil cytoplasmic antibody Anti-glomerular basement membrane Antibody to hepatitis B core antigen ‘Antibody to hepatitis B surface antigen ‘Australia and New Zealand Dialysis and Transplant Antiphospholipid antibody Antiphospholipid syndrome American Society for Histocompatibility and Immunogen American Society of Transplantation Bone mineral density Body mass index C3 glomerulopathy C3 glomeralonephritis Coronary artery disease Complement Factor B Complement Factor H Complement Factor 1 cerval iney disease Chronic kidney disease GFR category 45 chronic kidney disease GFR category 5 Chronic kidney disease-mineral and bone disorder Cytomeaglovirus Conference on Guideline Standardization Calculated panel ceactive antibody Canadian Society of Transplantation Computed tomography Cardiovascular disease Direct-acting antiviral Dense deposit disease iaberes mellitus Direct oral anticoagulant Donor-specific antibody EBV nuclear antigen Epstein-Barr virus Expanded-criteria donor lectrocardiogram Ehlers-Danlos Syndrome Estimated glomerular filtration rate Esophagogastroduodenoscopy Europcan Renal Association-European Dialysis and Transplantation Association Evidence Review Team European Society of Cardiology End-stage kidney discase Frailty Index Focal segmental glomerulosclerosis, Factor V Leiden Glomeculae filtration rate Grades of Recommendation, Assessment, Development and Evaluation Glyeated hemoglobin Hepatitis I surface antigen Hepatitis B virus 2020 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited,‘S10 Transplantation a Ape12020 a Volume 108 mt Number aS vrwarearsplanjoumal.com HcbD LepD LHcDD LN LVEF MDRO MET MGuUS MI MIDD MMR MN MPGN NaT NoDAT NYHA ‘Copyright: Heavy chain deposition disease Hepatitis C vieus Hepatitis D virus Heparin-induced thrombocytopenia Human immunodeficiency virus Human leukocyte antigen Hazard ratio Herpes simplex virus Human T-cell lymphotropic virus Hemolytic uremic syndrome Intracranial ancurysm ‘Immune complex-mediated MPGN IgA nephropathy Kidney Disease: Improving Global Outcomes Kidney Disease Outcomes Quality Initiative Kidney Health Australia-Caring for Australasians with Renal Impairment Light chain deposition disease Light and heavy chain deposition disease Lupus nephritis Left ventricular ejection fraction Maltdrug resistant organisms Metabolic equivalent Monoclonal gammopathy of undetermined signifi: Myocardial infarction Monoclonal immunoglobulin deposition disease Measles, mumps, or rubella Membranous nephropathy Membranoproliferative glomerulonephritis Nucleic acid rest(ing) New-onset diabetes after transplantation New York Heart Association Odds ratio Peripheral arterial disease Pulmonary actery systolic pressure Plasma cell dyserasia Phospholipase A2 receptor Purified protein derivative Pancl-reactive antibody Parathyroid hormone Randomized controlled trial Relative risk small interfering RNA Shiga toxin-associated hemolytic uremic syndrome Tuberculosis Transient ischemic attack ‘Transplantation Society of Australia and New Zealand United Kingdom United Network for Organ Sharing, United States Urinary tract infection Viral capsid antigen Varicella-zoster virus -020 Wolters Kluwer Health, Inc. Unauthorized ticle is prohibited,Seed ‘OPEN KDIGO Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation Steven J. Chadban, BMed, PhD,"* Curie Ann, MD, PhD,” David A. Axeirod, MD, MBA,° Bethany J. Foster, MD, MSCE, Bertram L. Kasiske, MD,” Vijah Kher, MD, DM,* Deepal Kumar, MD, MSc,” Rainer Oberbaucr, MD, PhD, Julio Pascual, MD, PhD,” Helen L. Pilmore, MD," James R. Rodrigue, PhD, "' Dom L. Segey, MD, PhD," Neil S. Sheerin, BSc, PhD,"° Kathryn J. Tinckam, MD, MSc,” Germaine Wong, MD, PhD," and Gregory A. Knoll, MD, MSc, * ‘Abstract: The 2020 Kidney Disease: Improving Glob Outcomes (KDIGO) Cinical Practise Guideline on the Evaluation and ‘Management of Candidates for Kidney Tneplantation is intended to assist heath care professionals worldwide who evaluate ‘and manage potental cancidstes for deceased or ving conor kidney transplantation, This quideine axkdrosses general candidacy ‘sues such as access to transplantation, patent demographic and health stalus factors, and ermunological and psychosoctel assesemert. The oles of various risk factors and comorbid conditions governing an incivdul’s suitably for vansplettion such as adherence, tobacco use, diabetes, cbesiy, perioperative issues, causes of dey tare, irfections, malgnancy, pulmonary cdocave, carciac and peripheral arterial disease, neurologic disease, gastontestinal and iver disease, hematologe disease, and bone ard mineral disorder are aso acckessed. This quideine provides recemmendktion for evaluation of inca aspects ofa Candidate's profle such that each risk factor and comorbidity are considered separately. The goals to assist the cical team to assimilate all data relevant to an individual, consider tis within tet localheal context, and make an oveal judgment on cand dec for transplarttion The gudelre developmert process folowred te Grades ot Raccrmmendation Assessment, Development, and Evauation (GRADE) approach. Guideline recommendations are pimaty based on systeratic reviews ofreleventstuces and cur assessment ofthe cualy ofthat evidence, and the strengths of recommendations are provided. Limitations ofthe evidence ‘are discussed wih ferences for previous guidelines noted and suggestions for fuure research are also provided. Keywords: albuminuria; achefence; bone and mineral metaboism; candidates; CKD-MBD; clinical practice guideline; cancer, cardiac disease; compatibliy; diabetes melitus; end-stage kidney disease; evidence-based recommendation; gas trointestinal disoase, genetic kidney disease; hematuria; hematological disorders; HLA; immunological assessment; infec- tious diseases; KDIGO; Keney transplantation; ver disease; maignancy; mineral and bone disorder, neurologic disease; obesity; pediatric; perioperative; peripheral atrial disease; pulmonary disease; psychosocll; systematic review; tobacco (Transplantation 2020;104: $1-8103) In ating this document, the folowing format should be used: Kidney Disease: Improving Glabsll Outcomes (KDIGO) Kidney “Transplant Candidate Work Group, KDIGO Cinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation. Transplantation. 2020;104; S1-S103, rca 6 January 2020 yal Pen atrac Hosptal and Chane Pakine Cana, Unieesty cf ye Shei Atala * Seo Nata Uwe Sou, Seuth Koren * Umvory ooo, low Cy ‘The Monoal Chikbn's Hosp McG Unkersty Haat) Cora, Moreen, coma > Hanno Coury Mca! Cat, Moneapets, MN *Macanta Keno aed Urlogy hstvis, Hana, da “Univeriy Heath Newer, Univesity of Trt, Teena, Canad “Mexia Unvorsty of Mera, Vana, Ati * Hosp dl Mar Buco, Sox kts Gy Hosp Anca, New Zane Bom era Daaconess Moka! Cs, Basin, MA Jens Hopkins Urivrsy Schoalof Maina Balinore, MO. ™ naweast Unvesy, Nowe, Unio Kingdom. sssnxon41- 109720710465 $1 a 10 1os7TOeaPeE00N0003 ‘Traneplontation = Apr 2020 m Velumo 104 m Number 4S 14 Unies ofSjcey, Siena 15 Mo Orava Hospi and Cri Hosp oscarch sino, Ona, Cana “GuebIno Wor Goup Cora: (Copy © 2020 KDXGO. Pusha by Wotars Maver Heath, bc This san oparaco2ss ariele asnbvte0 unc the arms oF the Give Comers Aitertien Conmmorca-No Derhatres Lcensa 40 (OO8YNO-ND wha iis pamsbb to downiad ae shar ths wok providbd ts proc ‘ted Ths otk eames bs changed in any wry or used commercial that ‘parnssin fom the pura. SUMMARY OF RECOMMENDATION STATEMENTS SECTION 1: ACCESS TO TRANSPLANTATION. 1.1: We cecommend that al patients with chronic kidney is- case (CKD) G4-GS (glomenalar firation rae [GFR] < 30 mi/min/1.73 m*) who are expected to reach end-stage Kidney disease (ESKD) (excluding those listed in Ree 1113) be informed of educated about and considered for kidney transplantation regardless of socioeconomic status, sex, ender idemtity, or racefethniciy (11), worn raneplaiounalcom st‘812 Transplantation a Ape12020 a Volume 108 at Number aS 1.1.4: Refer potential kidney transplant candidates for evaluation at least 6 to 12 months before antic pated dialysis initiation to facilitate identification! work-up of living donors and plan for possible pre-emprive rmpantaton (NF Grade. 1.1.2: Refer potential candidates already on dialy- sis when medically stable and kidney failure deemed irreversible (Not Graded). 1.1.3: We recommend not referring patients for ki ney alone transplant evaluation with the fol- lowing conditions (7D) Multiple myeloma (Ree 9.13.1.1), light chain deposition disease or heavy’ chain deposition discase (Rees 9.13.2.1, 9.13.2.2 tnd 9.13.2.3) unless they have received a potentially curative treatment regimen and axe in stable remission; + AL amyloidosis with significant extrarenal involvement (Recs 9.133.1 and 13.8); * Decompensated citthosis (consider for combined. liverkidney transplant; Rees 10.5.2.4.2, 16.7.2): + Severe inteversibie obstructive or restrictive lung disease (Ree 12.5}s + Severe uncorrectabie and symptomatic ear diac disease that is deemed by a cardiolo- bt precude tranopantaion (Ree 1 rrogressive central neurodegencrative dis: case (Rec 15.4). 1.1.3.1: Document the reason(s) for not refer- ring patients for teansplant evalua- tion (Not Graded). 1.1.3.2:Inform patients about the reason(s) for not referring for transplant evalu- a We weuction (Not Graded). , 14 We recommend delaying transplant evalua- sion in patients with the following conditions until properly managed (1D): An unstable psychiatric disorder that affects decision-making or puts the can date at an unacceptable level of post-teans- plant risk (Rec 4.2); * Ongoing substance use disorder that affects decision-making or puts the candidare at an unacceptable level of post-transplant risk (Ree 4.3); ‘* Ongoing, icalth-compromising nonadher- ent behavior despite education and adher- ence-based counseling (Ree 5.4}; + Ache infection (excluding, hepatis| ‘virus infection) that is not properly treated (Ree 10.1.1); pow + Active malignancy except for those with indolent and low-peade cancers such as rostate cancer (Gleason score < 6), and identally detected renal tumors (5 em in maximum diameter) (Reg 11.2.1) + Active symptomatic cardiac disease (es, angina, arith art falar, valvular hneart disease) that has not been evaluated byacardologis (Ree 13.2 + Active symptomatic peripheral arterial dis- cose tee BS * Recent stroke or transient ischemic attack (Ree 15.1)5 ‘* Active symptomatic: peptic ulcer disease (Rec 16.2.2); diverticulitis (Rec 16.3.1), acute pancreatitis (Rec 16.4.1), gallstoned gallbladder discase (16.5.1), inflammatory Bowel disease (Rec 16.6.1); vrwarearsplanjoumal.com ‘= Acute hepatitis (Ree 16.7.2); ‘= Severe hyperparathyroidism (Ree 18.2). ise a multidisciplinary team, which includes at a minimum a transplant physician, transplant sur- gcon and a health care pro ional experienced in the psychosocial aspects of transplantation, to eval- uate and decide about suitability for kidney trans- Blantation (Not Graded), : 7 no Eu sa wie tae according to national standards (Not Graded). 1.3.1: Inform patients of their option to seck a sce- ‘ond opinion from another transplant center if they are declined (Not Graded). fe recommend pre-emptive transplantation with a living kidney donor as the preferred treatment for ‘ransplanteligible CKD padents (1A). 1.4.1: We recommend pre-emptive transplantation (living or deceased donor) in adults when the estimated glomerular filtration rate (GFR) is < 10ml/min/1.73 mor earlier with symp- toms (1D). 1.4.2: We recommend pre-emptive transplantation (living or deceased donor) in children when the eGER is < 1Smbmin/1.73 m* or earlier vwith symptoms (1D). 13: SECTION 2: AGE 2 ‘onsider age in the context of other comorbidities, including frailty, that may impact outcome when deciding about suitability for kidney transplanta tion (Not Graded). 2.1.1: We recommend not excluding patients from kid ney transplantation because of age alone (7A). SECTION 3: PEDIATRIC ISSUES a e suggest performing a neurocognitive assessment in pediatric candidates who experienced end-stage kidney disease before the age of 5 years (2D). ‘We suggest performing, an academic assessment in pectic catdidane of school age who are expe: cencing academic difficulties (2D). ‘SECTION 4: PSYCHOSOCIAL ASSESSMENT 4.1: We suggest performing a psychosocial assessment in all candidates (2D). Refer candidates to a health care professional cexpericneed in the psychosocial aspects of kidney sraneplaaton (scl woes peso, psychiatrist, psychiatric nurse/aurse practitioner to perform this assessment (Not Graded). 4.1.2:Use measurement tools completed by the patient and/or evaluating clinician to supple- ment the assessment (Not Graded). 4.1.2.1: We suggest not using measurement tools in isolation to determine trans- plant candidacy (2D). 4.1.3:Refer candidates with a diagnosable psychiat- ric or psychological condition, substance use disorder or nonadherence for pre-transplant ccounscling and services to enhance the likeli hood of a favorable post-transplant outcome (Not Graded).e200 42: 433: 4s Wokers Khance ‘We recommend not transplanting patients with an unstabk. peychiatsie donde that affects decision making of puts the candidate at an unacceptable level of post-transplant risk (10). We recommend not transplanting patients with ‘ongoing substance use disorder that affects deci- sion-making or puts the candidate at an unaccepta- ble level of post-transplant risk (IC) ‘We suggest that patients without current social sup- port be considered for kidney transplantation if they are able to care for themselves and have an identified support plan in place prior to transplantation (2D). SECTION 5: ADHERENCE Sas 52) Sai Assess adherenoe and adherenes barriers pre-trans- tation to allow for appropriate education, coun- scling and post-transplant surveillance (Not Graded). Refer candidates with a history of health-compro- mising nonadherent behavior or identified adher- ence Barriers for adherence-based education and counseling pre-transplant (Not Graded). : We suggest that candidates with a history of graft loss due to nonadherence undergo adherence-based. counseling prior to re-transplantation (2D). We recommend that candidates with a history of nonadherence be considered for transplantation unless there is ongoing, health-compromising, non- adherent behavior (1D). SECTION 6: TOBACCO 6.1: 62) 63: 6A: 6.51 Assess past and present use of tobacco products b candidates at teansplant evaluation and while on the waiting lise (Not Graded). We recommend counseling ail candidates to avoid tobacco products before and indefinitely after trans- plantation (18). }: We recommend offering a tobacco cessation program: ci rai. tocandhates who are Gang tobacco procs [ Me recommend. that candidates” stan, from tobacco tue t'4 minima I month prior 0 wale tearm tanelataon HB} We suggest chest computed tomogeaphy (CT) for Sistas an tohsca tare 80 pace 3) as per foal guidlines to sree for occult Ting cancer (20), SECTION 7: SURGICAL ISSUES INCLUDING OBESITY Ta: 72: 731 ‘We recommend candidates to have their body habi- tus examined by a transplant surgeon at the time of evaluation and while on the waiting list (1B). 7.11: We supgest that candidates not he excluded from intation because of obesity as defined by oa onl ass index o wai tohip ratio) (2B). :We suggest weight loss interventions be fice candidates with obey peor fo transplantation (2D) ‘We suggest that candidates be assessed for frailty at the tne of evaluation and while on the waht ro inform post-transplant risk and enable optimizat strategies, such as pre-operative rehabilitation (2G ‘We suggest that candidates be assessed for medi cal conditions that inhibit wound healing, includ- ing obesity, undernutrition, tobacco use, and prior abdominal’ surgeries, to inform risks of delayed. ‘wound healing and hemia formation (28). S13 7A: Candidates should not be exchded frm consideration tre sample fc al or anticoagulation, antiplatelet therapy ora history of hep- atin-induced thrombocytopenia (Fi) (Not Graded) Fal: Single antiplarcket agents (eg aspirin, clo dogrel,tcagrelor) can be continued while watt for decased donor rangplant (Not Graded) 7.42: Déay transplantation forte mandated peti of treatment with daalancipltle therapy 5, aspirin plus dopidogre} when the risk of op agmatine et trombone Ing while on treatment (og, st na) tects the andcpated berei of transplants ton (Nor Grad TADAsAniplaelc agents (except. aspirin) should be stopped 5 days prior tiv ing donor transplantation (unless ces- ston comand) and cing the perioperative period for deceased donor transplantation (Not Graded). Do. not transplant patents on direct acting oma antcoagilanrs (DOACS eg, spbtabar, aro) expe whe thet api txpartise using, DOACS_periopertivly a acees to DOAC reversal agents (Not Graded). 743-1: Seitch toan alteative anticoapulant (cg warfarin) prior to waitlsting or ifSag door transplantarion if rat mended bya thrombosis exper/hema- logs ori he sm ape ang DOXGS perioperaiely tae na ONC eral ges (Noe Graded ¢ non-heparin based agens for petiopers- tive antoongulation in cadidates with & bis- tory of TN Grad Assess vascular anatomy and patency for ‘with sigaficant peripheral arterial disease (eu 14), prior transplant procedures, venous dialysis caticters, pelvic surgery, or deep venous thrombosis (Nor Graded) Evaluate native kidney sie in patients with polycys- tic kidney disease (Not Graded). Tea: We suggest staged oF simultancous native nephrestomy and transplantation fr candidates woah polyeystic kidney disease that syimpto- tate (og fecrrent pain, recurrent infection), { aigpicbn of malgtaney, orf the patient has vee rin oa ang 20). tarps isl tisk for or those with a hse tory of urologic malignancy recurrent urinary tract infections, dysfunctional Yoiding. prior bladder ugmentation/dvision, an ileal condat, significant Structural anomalies of the kidneys or urinary trac, er pephaoihans (Nor Grad)” "0" We suggest atopy to screen fr bladder car com cane cei ich those wit high-level exposure to cyelophospha SOE necyuniieg Dol peace OO) ‘We suggest thar pretransplant unilamsal or bite nepssony be conaed fox pd ttre can ith high urine volumes (> 2.Simisagfhour) or heavy proteinuria as died wi hypoaibunincmia 2D). 743 7.53 ts 76: 77: SECTION 8: DIABETES 8.1: We recommend that candidates with type 1 or type 2 diabetes mellitus (DM) be considered for kidney transplantation (18).‘S14 Transplantation a Ape12020 a Volume 108 at Number aS 8.1.1: We suggest candidates with ESKD and type 1 DM be considered for simultancous creatkidney transplantation in regions whe this procedure s available 2A). 8.2: We suggest testing for abnormal glucose metabolism by oral glucose tolerance test in candidates who are not known to have diabetes (2A). ‘SECTION 9: CAUSE OF END-STAGE KIDNEY DISEASE (ESKD) 9.1 Canse of ESKD and kidney mansplantation SAT: We recommend that the eanse of ESKD in candidates be determined, where possible, to inform risks and management after kidney transplantation (1). 9.12: Adve candidates sbout the disease-specific Fisk of recurrence ond resultant Fk of graft loss (Not Graded). 9.2 Focal segmental glomerulosclerosis (FSGS) Sot: We recomend not cluding candies with primary FSGS from kidney transplantation; however, the risk of recurrence should be con- sired and dcussed with the candidate (1), 92.141: Loss of a prior graft duc to recurrent FSGS indicates a high risk of recurrence ‘upon subsequent transplantation and this factor should be a major consideration in iecrminng candida (Not Graded 9.22: We suggest genets texting (for podoin ¢ mutations, among. others) in chikien avd youn aul I couree consistent with genetic to inform the risk of recurrence (SC) 9.2.3: We sugest avoiding routine use of pre-trans- plant finma exchange or ruximabo reduce fherdk of recurent $80 2D). 9.3 Membranous nephropathy (MN). Su: We recommend tor excluding candidates wvith MN from kidney translation; how. ever, the risk of recurrence should be consi ered and discussed withthe candidave (1B) 93.1.1: We suggest not exclnding candidates ‘with prior graft loss due to MN; how- ‘ever, the risk of recurrence should be considered and discussed with the candidate (2D). 9.32: We suggest that autoantibodies to phosphol- pase A? receptor (PLA2R) be measured pro- transplant to inform the risk of recurrence in ss Guia with MN 20), sana alkylating agents to rediice the risk of recur: rent MN (20). 944 IgA nephropathy (aN) SURE onl oe cosa candies with IgAN from kidney transplantation; howeves the risk of aie aed be considered and discussed with the candidate (1B). 9. Iga ws 5.1; We recommend not excluding candidates with Iga vasculitis rom kidney wansplantar tion; however, the risk of recurrence should be considered and discussed with the cand date (1B). 9.6 Immune complex-mediated membranoproliferative Jomerulonephrits (ICMPON and Co glomere: pathy (C36) vrwarearsplanjoumal.com 9.6.1 1C-MPGN 9.6.1.1:We recommend not excluding can- didates with ICMPGN from kidney transplantation; howeves, the cisk of recurrence should be considered and discussed with the eandidace (1B). 9.6.1.2:We recommend investigation for an infective, autoimmune, of parapro- tein-mediated cause of ICMPGN rior to transplantation to guide Treatment and inform risk of recur rence (IC). 9.6.1.3:We suggest thar, when possible, the cause of the ICMPGN be treated prior to transplantation (20). 9.6.2. €3G, including dense deposit disease (DDD) and C3 glomerulonephritis (C3GN) 9.6.2.1:We recommend not excluding can- didates with C3G from kidney transplantation; however, the cisk of recurrence should be considered and discussed with the candidate (1B). 9.6.2.2: We suggest that candidates with C3G be screened for genetic or acquired causes for the dysregulation of the complement alternative pathway to guide treatment and inform risk of recurrence (2C). 9.6.2.3: Loss of a prior graft due to recurrent €3G indicates a high risk of recur- rence upon subsequent transplanta tion and this factor should be a major consideration in determining, candi- dacy (Not Graded). 9.7 Lupus nephritis (LN) 9.7.1: We recommend not excluding candidates with LN from kidney transplantations however, the tisk of recurrence shouldbe considered and di- cussed with the candidate (1B) 9.7.2:We recommend that lupus activity should be jally quiescent on no of minimal immu- ;osuppression prior to transplantation (1D). 9.7.3:We recommend evaluation for secondary antiphospholipid antibodies prior to. trans: plantation to inform perioperative manage- ment (1) 9.8 Antiphospholipid syndrome (APS) 9.8.1:We recommend not exchiding candidates with APS from kidney transplantation; how- eves the risks of post-transplant thrombosi and” perioperative anticoagulant therapies should be considered and discussed with the candidate (1B). 9.8.2:We suggest that APS should be clinically qui- «scent prior to transplantation (2D). 9.8.3:Continue anticoagulation (eg, aspirin, warfa- rin) at the time of activation on the transplant waiilist (Not Graded), 9.9 Anti-ncutrophil cytoplasmic antibody (ANCA)- associated vasculitis 9.9.1:We recommend nor excluding can with ANCA-associated vasculitis from ki transplantation; however, the risk of recur. rence should be considered and discussed with the candidate (7B). 9.9.2:We suggest that ANCA-vasculitis should. be ically quiescent prior to transplantation QD).(© 2020 Weters Kiwer 9.10 Anti-glomerular basement membrane (anti-GBM) disease 9.10.1:We recommend not excluding candidates with anti-GBM discase from kidney trans- plantation (7B). 9.10.2:We recommend that anti-GBM antibody titers be measured in candidates and that transplantation is only performed when Shtlbodies are undetectable (1D) uuremie syndrome (HUS) 9.11.1: We recommend not excluding candidates \with HUS due to infection with a Shiga-toxin producing organism, usually E. coli (STEC- HUS), from kidney transplantation (1). 9.11.2:We recommend assessment of candidates with suspected atypical HUS (aHUS) for a genetic or acquired defect in complement regulation or other genetic causes of aHlUS to inform risk of recurrence (1B). 9.11.3: We recommend not excluding candidates with aHUS from kidney transplantation; however, the risk of recurrence should be considered and discussed with the candidate (1B). 9.11.31: We recommend that if the can- didatg has an_abmormaliy in complement regulation plac fhensr hgh Sak of redrem, kidney transplantation should ‘not proceed unless a complement inhibitor can be administered or combined liverkidney transplant can be performed (1B), 9.12 Systemic sclerosis 9.12.1:We recommend not exciuding candi- dates with systemic sclerosis from kiclney transplantation in the absence of severe pulmonary, gastrointestinal, or other life= threatening extearenal disease (1C). 9.13 Plasma cell dyscrasias (PCDs} Please consult Section 17.6 Hematologic Disorders for recommendations related to monoclonal gammopathy of undetermined significance (MGUS) 9.13.1 Multiple mycloma 9.13.1-1: We suggest that candidates with multiple mycloma be excluded from kidney — transplantation unless they have received a poten- tially curative treatment regimen and are in stable remission (2D). 9.13.2 Monoclonal immunoglobulin deposition disease (MIDD} 9.13.2.1: We suggest that candidates with light chain deposition disease (LCDD) be excluded from kidiney transplantation unless they have received 4 potentially curative treatment regimen and are in sta ble remission (2D). 9.13.2.2: We suggest that candidates with heavy chain deposition disease (HICDD) be excluded from kid- ney transplantation unless they have received a potentially cura- tive treatment regimen and are in stable remission (2). 9.13.2.3: We suggest that candidates with light and heavy chain deposition disease (LHCDD) be. excluded from kidney transplantation 315 unless they have received a poten= tilly curative teatment seinen and are in stable remission (2D). 9.133 AL amyloidosis 9.13.31: We suggest that candidates with AL. amyloidosis be excluded from Kkidoey teansplantation unless they hhave minimal extrarenal disease (cgcardiac amyloid) have received 2 potentially ‘curative treatment ‘ogmen and are in stable remission (2D) 9.14 AA amyloidosis 9.14.1: We recommend not excluding candidates with AA amyloidosis from kidney trans- plantation after adequate treatment of the underlying cause and in the absence of severe extrarenal organ involvement (7). 9.15 Fibrillary/immunotactoid glomerulonephritis 9.15.1: We recommend not excluding candi- dates with fibrillary or immunotactoid glomeralonephritis from kidney trans- Plantation; however, the risk of recur- rence should be considered and discussed with the candidate (1D). 9.16 Hyperoxaluria (oxalosis), primary and sccondary 9.16.1: We suggest that candidates with primary hyperoxaluria type 1 be considered for combined or sequential iverkidney trans- lantation (20) 9.16.2: We suggest genetic testing to identify the ‘cause of primary hyperoxaluria to inform treatment decisions (20). 9.16.3: We suggest nor excluding candidates with responsive or “stcondary—irom kidney transplantation alone; however, the risk of recurrence should be considered and dis- ssussed with the candidare (2D). 9.164:We recommend the usc of siratogics to lower total body oxalate burden prior to transplantation in. patients with hyper- oxaluria, including intensive dialysis, diet modification, and pyridoxine treatment as. appropriate on a case-by-case basis (1D). 9.17 Cystinosis 9.171: We recommend not excluding candidates with cystinosis from kidney transplanta tion in the absence of severe extrarenal manifestations (10). 9.18 Fabry disease 9.1841: We recommend not excluding candkates with Fabry disease from ki planta Hon in the absence of eeverecardise or other systemic extrarenal ongan involvement (1C) 9.19 Sickle cell disease 9.19.1; We recommend not excluding candidates with sickle cell disease from kidney trans plantation in the absence of active, severe extrarenal sickle cell disease (IC). 9.20 Sarcoidosis, 9.20.1: We recommend not excluding candidates with renal sarcoidosis from Kidney trans- plantation in the absence of severe extrare- nal disease (IC). 9.21 Alport syndrome 9.21.1; We recommend not excl ‘with Alport syndrome from kidney trans- plantation (1C).‘S16 Transplantation a Ape12020 a Volume 108 at Number aS vrwarearsplanjoumal.com ‘SECTION 10: INFECTIONS 2.1:We recommend screening all tients for HCV infection 10.1 Active infections Tia) (KDIGO HCV Guideline 10.1.1: We recommend that kidney transplantation Recommendation 1.1:4) be delayed until ative infections (bacterial, 10,5.2.2: Werecommend using an immuneas- fungal, vial [except hepatitis C}, parasitic} say followed by nucleic add testing are treated (IC): (NAT) if immunoassay is positive 10.2 Colonization (1A). (KDIGO HCV ‘Guideline 10.2.1:Follow loc Recommendation 1.1.1.1) management of colonization with deug- 10.5.2.3:We recommend ‘kidney trans- resistant organisms (Not Graded). plantation as the best therapeutic 10.2.2: We recommend not excluding patients from option for patients with CKD GS kidney transplantation with asymptomatic irrespective. of presence of HCV bacterial, parasitic or fungal colonization infection (TA). (KDIGO HC! ag. Guideline Recommendation 4.1.1) 10.3 Specific Infections 24: We suggest that all candidates 10.3.1 Urinary tract infections (UTIs) with HCY infection be evaluated 10.3.1.1: We recommend treating, sympto~ for severity of liver disease and matic UTIs prior to kidney teans- presence of portal hypertension (ir plantation (1B). Indicated) prior to acceptance for 10,3.1.2: We suggest not routinely perform kidney transplantation (Figure 3) ing prophylactic nephrectomy for (2D). (KDIGO HCV Guideline recurrent pyelonephritis or cyst _ Recommendation 4.1.2) infections (2D). 105.24.1:We recommend — that 10.3.2 Tuberculosis (TB) paticats with HCV and 10,3.2.1: We suggest complete treatment of Compensated cizehosis active TB prior to kidney tans: (without portal hypertea- plantation, as per World Health sion) undergo isolated kid- Organization or local guidelines ney. transplantation (1B). 20. {KDIGO HCY Guideline 10,3.2.2:We ‘recommend. sereening for tecommendation 4.1.2. latent TB at the time of candidate 105.2425 "commend rele evaluation in low TB prevalence ring patients with HCV areas with a chest radiograph and decompensated tosis. 5 for combined liverkidney — transplanta- tion (1) and. de HCV treatment u transplantation (1D). (KDIGO HCV Guideline Recommendation 4.1.2.2) 5: Timing of HCV treatment in rela- tion to kidney transplantation {before vs. after) should be based ‘on donor type (living vs. deceased donor), waitlist times by donor along with a purified protcin derivative (PPD) skin test or inter- feron-gamma release assay (IC) 10.3.2.3:We suggest starting treatment of latent TT prior to or immediately following ‘kidney transplantation in low TB prevalence areas (2C). 10.3.24:We suggest screening for latent ‘TB at the time of candidate evalu- ation as per local guidelines in intermediate and high TB preva- lence areas with post-transplanta- mor), sya imes by “donoe on vigilance for active TH (2C) eS er cee for periodontal disease HCV-infected deceased donors, je suggest dental evaluation, as per local Hey pepe and _Reneral population guidelines, co sereen for oflivee threes (NOE dentallpestodontal dase prio o kidney IKDIGO HCV Guideline transplantation (26). Recommendation 4.1.3) cening for viral infections (sce Table 11) LOS2STWe recommend. thac all 10.5.1 Human immunodeficieney virus (HIV) patients with HCV. who 105.11:We recommend screening all re candidates for kid patients for HIV infection, using ney transplantation be HIV serology (1). considered for direct- 10.5.1.2:We recommend not exchiding acting antiviral (DAA) patients with controlled HIV therapy, either before or infection feom kidney transplan- after transplantation (14). tation (10). (KDIGO HCV Guideline 10.5.1.3:Kidney transplant candidates Recommendation 4.1.3.1) with HIV should be managed in a 105.2.5.2:We suggest that candidates «center with experience inthis arca with HCY with a living kid (Not Grided). ney donor can be consid 10.5.2 Hepatitis C virus (HCV) [This section cred for treatment before is “adapted from 2018 KDIGO HCV or after transplantation Guideline] according to HCV genorype(© 2020 Weters Kiwer and anticipated timin of. transplantation (28) (KDIGO HCV Guideline Recommendation 4.1.3.2) 10.5.2.5.3:We suggest that if receiv- nga kidney from an HCV. positive donor improves the chances for transplanta tion, the HCV NAT-positive patient can undergo trans- plantation with an HCV" positive kidney and be treated for HCV infection afer transplaneation (28). (KDIGO HCV Guideline Recommendation 4.1.3.3) 10.5.3 Hepatitis B virus (HBV) [Soe Section 10.7 for related recommendations on HBV vacsinations| 10.5.3.1:We recommend _sereening for HBV infection with HBsAg, anti- His, and anti-HBe (TA). : We ‘recommend screening, with HBV DNA for patients with a Gestive HBsAg or anit (14). 10.5.3.3:We recommend. ‘that patients from hepatitis D_ virus '(HDV) endemic areas be screened with HDV scrology if they are positive for HBsAg or anti-HBe (1A). 10,5.3.4: We recommend that HBsAg, posi- tive and/or HBV DNA positive candidates be referred 0 a spe- cialist with expertise in the man- agement of liver disease and HBV infection to determine appropri- ate antiviral treatment (1D). 10.5.3.4.1:We recommend that HBsAg, positive and/or HBV DNA positive candidates undergo isolated kidney cransplan- tation if they do not have decompensated citthosis, and are stable on antiviral 105.3 therapy after specialist eval- uation (1B). 105.3.5:We recommend not exchud: ing anticHBe antibody positive (HBsAg negative) patients from kidney transplantation (I). S.A: We recommend that anti- 10 Human T-cell lymphotropic sv (VCA) IgG andlor EBV nuclear autigcn (EBNA) IgG (1). 10.5.6 Herpes simplex virus (HSV) 10.5.6.1:We suggest screening for HSV with HBV IgG 2c). 10.5.7 Varicella-zoster virus (VZV LO.s7a1sWe recommend screcning. for VZV with VZV IgG (10 105.741-We recommend varicella Immsniation for WAV seronegative candidates at Kea 4 weeks prior 60 transplantation (16, Measles, mumps; and rubella (MMR) Je sungest screening for MMR WIR sorology (20). MWe sugget MIM imman= ration bop MMR serongn= tive, candidates at feast 4 wrecks prior to transplanta- tion 20. 10.5.9 BK virus 10.5.9.1:We recommend not screening for BK virus infection in candidates ag. 10.5.9.1 4: We recommend not exclude ing patients for repeat transplantation if a previ- fous graft was lost due to BK nephropathy (1C 10.5.10.1: We recommend HTLV 122 with IgG serology in ‘candidates from endemic areas as per World Health Organization 10.6.1 Syphilis ag. 10.6 Screening for non-vieal infections 10.6.1.1:We sccommend screcning for syphilis (Treponema _pallidur) with serology at the time of can- sire cation and renee prior to transplantation if infec tion is identified (10), 10.6.2 Strongyloides 10.6.2:1: We suggest screening for strongy- loidiasis with serology at the time of evaluation in candidates from endemic areas, and treatment prior to transplantation if infec tion is identified (2C). HBe antibody positive 10.6.3 Chagas disease (HBsAg negative) patients 10.6.3.1:We recommend screening for not receive antivical proph- Chagas discase with serology at ylaxis given that the risk of the time of evaluation in eandi- feactivation slow (1D). dates from endemic areas) and .2:We suggest that ant-HBe treatment prior to transplantation. antibody. positive (HBsAg, if infection is identified (1C negative) " patients have 10.6.4 Malaria a plan in place for post- 10.64.1:We recommend screening for transplant monitoring of malaria with a malaria blood HBsAg and HBV DNA for smear at the time of evaluation a minimum of T-year post= in candidates who have recently transplantation 2). travelled to endemic areas, and 10.5.4 Cytomegalovirus (CMV) treatment prior to transplantation 10.5.4.1:We recommend screening for if infection is identified (1) CMV with CMV IgG (1C), 10.7 Vaccinations 10.5.5 Epstein-Barr virus (EBV) 10.7.1:We recommend that the vaccination 10.5.5.1: We recommend screening for EBV series be commenced using an acceler- with EBV viral capsid” antigen ated schedule, if necessary, prior to kidney‘S18 Transplantation Ape12020 a Volume 108 at Number aS transplantation for any inactivated vac- ines (Table 12) (1B). 1O7-AA:We suggest not excludl es who do not complete an fated vaccine series prior to kidney transplantation (2). 10.7.2: We recommend that the vaccination series be completed prior to kidney transplan- tation for any live attenuated vaccines (Table 12) (18), 10,7.241:We recommend a 4-week delay in kidney transplantation if a live vaceine is administered (eg, MMR, VZV, shingles, yellow fever, oral typhoid, oral polio vac~ sinc) (1B). 10.7.3:We recommend that splenectomized can- didates or those at increased risk for post-transplant splenectomy receive. pre- transplant pneumococeal, hemophilus, and ‘meningococcal vaccination (1B). 10.7.4:We recommend that candidates requiring ‘complement inhibitors perioperatively of post-transplant undergo meningococcal Yaccination (1), he fol 10.7.5:We suggest administering the following, vaccines to candidates who, due to age, direct exposure, residence of travel to endemic areas, or other epidemiological risk factors, are at increased risk for the specific diseases: *# Rabies (2D) + Tick-borne meningoencephalitis (2D) + Japanese encephalitis (inactivated) (2D) + Meningococeus (2D) + Salmonella typhi (inactivated) (2D) *# Yellow fever (2D) 7 SECTION 11: MALIGNANCY 11.1 Cancer screening T1L.1: "We recommend candidates underge routine cancer screening, as per local guidelines for the general population (Table 13) (1D). LL-L-LA: We suggest chest imaging prior to transplantation in all candidates 2). Same as Ree 12.2) 11.1.1.2:We suggest chest GI for current ‘or former heavy tobacco users (@ 30 pack-years) as per local guidelines, and chest radiograph for other candidates (2C). (Same as Ree 12.2.1) 11.1.2:Scrven candidates at incseased tisk for renal ell carcinoma (eg > 3 years , fami history of ronal cancer acquired cystic i case or analgesic nephropathy) with ultra- sonography (Not Graded). 11.1.3: We suggest cystoscopy to screen for blad- der carcinoma in candidates at incecased risk, such as those with high-level exposure to cyclophosphamide or heavy smoking (= 30 pack-years) (2D). 11.1.4: We recommend sercening for hepatocellu- lar carcinoma in candidates wit prior to transplantation using, techi vrwarearsplanjoumal.com (es, ultrasound, «feroprotein) and fre- fqucncy as per local guidelines (IC) : We recommend seteening for bowel cancer Cauldates wich inflammatory bowel di tase as po local guidelines (10). 11.2 Potenial kidney transplant eandidaes with a prior 112: TeWe recommend that candidates with active malignancy be excluded from kidney trans Plantauon except for those with indolent End low-grade cancers such as. prostate Cancer (Gleason score © 6), superfigal non wclanoma skin cancen, and” inckdcoeally Aletecred renal tumors (& Yer in maxiimicn diameter) (8) Taming oy anplaaion afr mally curative treatment for cancer Sependent on the cancer type and stage at inital diognoss (Nor Graded). 11.23:We recommend no waiting time for end lates with curaively treated (surgically oF cthcrwsc) nonmetastatic basal cell aad Squamous cell carcinoma of the skin; mela- noma i sisal cena cell agsinoma (< Sem prostare cancer (Gleason score © 6); carcinoma st (dacal arcnoma sity serves thes tytn! cane (ele spillary = 2emn of low grade histology) Bil superficial bladder eascer (10). T2Sstor omer cance west lowing, wating time parameters asoutined n fable 14 20) 11.2.2: We agest thatthe recommended vals time from cancer to kid hey transplantation begins upon Completion of potentially curative tteatment 2D) 11.24:Decisions about tansplantation for can- dlidates in remission from. cancer should te made collaboratively with oncologist, tramplant. nephrologsts patients, Sand thelr caregivers (Not Graded). TdAactsFor relevant cancers, suppk- mont estimates of prognosis Wang nome profiling, other molecte fr genomic tet and. phen iyping.in consultation. with the putcn’s oncologist (Nor Grad 1.2.5: Werecomendnoc exclu candidates with a history of metastatic cancer provide that potently curative therapy as een ans {ered and complete remison aclacted; how. the the ak of recurrence should bea major Sonctkration and dscused with the cand date and ther oncologist (1D). 11.3 Hematologic malignancy (see Sections 17.7, 17.8 and 179) TI:3.4 Acute Tookemin and high-grade phoma, including post-tansplantIymphoprokiteative dlscase T1lc1: Avoid transplanting patients with Kekchi st ave Tecetvedeuratve. therapy Achieved remision and remaited Gancer free for a period to. be ernie in 'conelaon ith the patent « hematologsfoncol- opi and the transplant prom (Rot Graded). POP LAS:(© 2020 Weters Kiwer 11.3.2sMyelodysplasias, chronic leukemia and chronie/low-grade lymphoma 11.3.2d:Decisions about. kidney trans- plantation in patients with mye- lodysplasia should be made in collaboration with a hematologist (Not Graded). 11,3.2.2: Advise consultation with a hema- tologist with transplant cxperi- ence in determining, transplant candidacy since many lesions may. be deemed to be at high risk of accelerated progression or trans- formation post-transplant (Nor Graded). Decisions about’ kidney transplantat in patients with a prior history of hema tologic malignancy who are now in remis- sion should be made in collaboration with a hematologist (Not Graded). 1.3.31 SECTION 12: PULMONARY DISEASE 12.1: Assess candidates with lung disease in collabora- tion with a pulmonary specialist to determine suit- ability for transplantation (Not Graded). 12.2:'We suggest chest imaging prior to transplantation in all candidates (2C). (Same as Rec 1.1.1.1) 12.2.1 We suggest chest CT for current or former heavy tobacco users (2 30 pack-years) as cr local guidelines, and chest radiograph jor other candidates (2C). (Same as Ree WA.1.2) 12.3: We recommend pulmonary function testing in ean- didates with impaired funetional capacity, respira- tory symptoms, or known pulmonary disease (1). 12.4: We recommend counscling all candidates to avoid tobacco products before and. indefinitely after transplantation (1B). (Same as Rec 6.2) 12.5: We recommend excluding patients with severe irreversible obstructive or restrictive lung disease from kidney transplantation (1C).. SECTION 13: CARDIAC DISEASE 13.1:Evaluate all candidates for the presence and severity of cardiac disease with history, physical examination, and electrocardiogram (ECG) (Not Gre). ‘ 13.2:Patients with signs or symptoms of active car tac disease loge angina, arrhythmia, heat ure, symptomatic valvular heart disease) should undergo assessment by 2 cardiologist and be man- aged according to current local cardiac guidelines por to hrther considerstion for a kidney trans plant (Not Graded) 13.3: We suggest char asymptomatic candidates at high risk for coronary artery disease (CAD) (eg, dial tes, previous CAD) or with poor functional capac- ity undergo non-invasive CAD screening (2C). 13.3.1: We recommend that asympto- matic candidates with known CAD not be revascularized exclusively to reduce perio Qerrivecaiag events (7B). We suggest. that patients with asymp- tomatiey advanced” triple vers coro: nary disease be excluded from kidney S19 transplantation unless they have an esti- mated survival which is acceptable accord ng to national standards (2D) 13.4:We suggest that asymptomatic candidates who have been on dialysis for at least ewo years or have risk factors for pulmon eg, portal hypertension, connective tissue disease, congenital heart disease, chronic obstructive pulmonary dis- cease) undergo echocardiography (2D). ints with an estimated pulmonary. syst pressure greater than 45mm Hg by echocardio- ‘graphic criteria should be assessed by a cardiolo- ist (Not Graded). 3.5.1: We recommend not excluding candidates with uncorrectable pulmonary artery sys- tolic pressure greater than 60mm Hg, ed from right heart catherization} idney tcansplantation; however, the risks of sudden deterioration or progres- Sion after transplantation should be a key consideration and the patient should have fn estimated survival which is acceptable ng to national standards (1). severe valvular heart disease should beevalnated and managed by a cardiologist accord ing to local cardiac guidelines (Not Graded). e suggest that patients with uncorrectable, symp- tomate New York Heart Association (NYHA) Functional Class IIVIV heart disease [severe CAD; left. ventricular dysfunction (ejection fraction < 30%); severe valvular discasc] be excluded from kkidney transplantation unless there are mitigating factors that give the patient an estimated survival which is acceptable according to national stand- ards (2D 13.7.1:Patients with severe heart failure (NYHA MMV) who are otherwise suitable fr ki ney transplantation should be assessed by a cardiologist and considered for combined simaltancous heart and kidney transplan- 1s Pecfomtion. Not Graded). sh yn amyloidosis, Exclude sich patents from kidney transplantation if significant cardiac amyloid is infarction be assessed by a cardiologist to deter mine whether further wsting is warranted and ‘when they can safely proceed with kidney trans- plantation (2B). ' 13.10:We suggest that transplantation be delayed an appropriate amount of time after placcment of a Coronary stent as recommended by the patient's car- diologist (28). 13.11:We suggest that maintenance aspirin, B-blockers, ‘and statins be continued while on the waiting list and perioperatively, according, to local cardiac guidelines (2A). B.S: 13.61 ‘SECTION 14: PERIPHERAL ARTERIAL DISEASE (PAD) 14.1: Evaluate all candidates for presence and severity of peripheral arterial disease (PAD) with history and physical examination (Not Graded). 14.2:We suggest that candidates without clinically apparent PAD, but who are at high risk for PAD, undergo non-invasive vascular testing (2D)SECTION 1 LIVER DISEASE ‘$20 Transplantation a Ape12020 a Volume 108 a Number aS 1a Candidates with dinically apparent PAD should undergo imaging and management of their PAD in consultation with a vascular surgeon prior to transplantation (Not Graded). 144: We suggest thar candidates with clinically appar ent PAD, abnormal non-invasive testing, or prior vascular’ procedures, undergo non-conirast_ CT imaging of the absomen/pelvis to evaluate arterial caleifieation and improve operative planning (2D). 14.5:Exelude candidates with non-healing extremity ‘wounds with active infection from transplantation until the infection is resolved (Not Graded). 14.6:We suggest not excluding patients with prior aorto-iliac procedures including iliac artery stent placement from Kidney transplantation if there fs sufficient native artery available for vascular mastomosis 2D). ; 14.7:We suggest not excluding patients with severe aorto-iliac disease or distal vascular disca from kidney transplantation; however, the risk of progression after transplantation should be a key consideration and the patient should have an estimated survival which is acceptable according to national standards (2D). SECTION 15: NEUROLOGIC DISEASE 15.1: We suggest waiting at least 6 months after a stroke for 3 months after a transient ischemic attack (TIA) before kidney transplantation (2D). 15.2: We recommend not screening asymptomatic can- didates for carotid artery disease (1D). 15.3: We suggest sercening, candidates with autosomal dominant polyeystic kidney (ADPKD) disease for intracranial aneurysms only if they are achigh risk due to prior history of or a family history of suba- rachnoid hemorrhage (2D). 15.4:Patients with progressive centeal neurodeges crative discase should not undergo kidney trans- plantation if survival and quality of life ace not expected to be substantially improved by trans- plantation (Not Graded). 15.5: Assess mental status in candidates with known or suspected cognitive impairment (Not Graded). 1535.1:We recommend not excluding candidates from kidney transplantation. because of non-progressive intellectual, developmen- tal, or cognitive disability (11D). 15.6: Patients’ with symptomatic peripheral ne ropathy should be assessed by a ncurologist (Not Graded). 15.6.1: We suggest people with progressive periph- cral neuropathy attributed to uremia be considered for urgent kidney transplanta tion, if available (2D). 15.6.2:We recommend not excluding candidates from kidney transplantation. because of peripheral neuropathy (1D). |ASTROINTESTINAL AND 16. Evaluate all candidates for the presence of ga troistinal hess nln Tver dei, wth a targeted history and physical examination (Not Graded." vrwarearsplanjoumal.com 162 Peptic ulcer dscase 162.1: We recommend that candidates with symp- ‘toms suggestive of active peptic ulcer dis- cease undergo esophagogastrascopy and H. fori testing prior to kidney transplanta: ton (10. 8 er 16.2.2:Delay kidney transplantation in candidates ‘with’ endostopically-proven pepe uler disease until symptoms have resolved (Not Graded). 16.2.3:We recommend not screening candidates wth s history of peptic uct disease with sophagogastroscopy (10) 16.2.4:We recommend not excluding candidates ‘with a history of peptic ulcer disease from kidney transplantation (1D). 16.3 Diverticulitis 16.3.1: Delay kidney transplantation in candidates ‘with active diverticulitis until symptoms have resolved (Not Graded). 16.3.2:We recommend not screening. asympto- mati candidates for divericaless (1) Ne sccommend noe perorming pron lacie colectomy in patients sath a history of diverticulitis or" asymptomatic diver ticulosis (1C). We recommend not excluding candidates with s history of diverticulitis from kidney Transplantation (10) 1644 Pancreatitis 16.4.1: Delay kidney transplantation in candidates ‘with acute pancreatitis a minimum of three months after symptoms have resolved (Not Graded). 16.4.2:We suggest not excluding candidates with ‘a history of acute or chronic pancreatitis from kidney transplantation (2€). 16.5 Choldithiasis 16.5.1:Delay kidney transplantation in candidates ‘with symptomatic gallstone or gallbladder disease until symptoms have resolved (Not Graded). We rermmenel that isolates wit a his- tomy before kidney transplantation (IC) 16.5.3:We recommend not screening, asyanpto- matic candidates for sSoleliuens {1C). 16.54: We recommend not performing prophy- lactic cholecystectomy in candidates with asymptomatic cholelithiasis (1C). 16.5.5:We recommend not cxcluding candidates ‘with asymptomatic cholelithiasis from kid- ney transplantation (1A) 16.6 Inflammatory bowel disease 16.6:1:Delay kidney transplantation in candidates with” active “symptomatic. inflammatory bowel discase (Not Graded). 16.6.1.1:Determine timing of teansplanta- tion for suet patients in coon (Not Graded). = @ We recommend screening for howe cancer incandidates with inflammatory bowel di cease as per local guidelines (1). (Same as Rec 11.1.5). 16.6.3:We recommend not excluding candidates With 2 history of inflammatory bowel dis case from kidney transplantation (1D). 16.3. 16.6.(© 2020 Weters Kiwer 16.7 Liver disease 16.7.1:Sereen kidney transplant candidates for liver disease with a toral bilirubin, alanine aminotransferase, international normalized tatio, and albumin (Not Graded) 16.7.2:Delay kidney transplantation until acute hepatitis, of any cause, has resolved and a long-term strategy for managing liver dis- case has been implemented (Not Graded). 16,7.3:We recommend that candidates with cir hosis or suspected cirrhosis be referred to a specialist with expertise in combined liver kidney transplantation for evaluation (1B). 16. We recommend that patients undergo isolated kidney trans plantation if deemed to have com- pensated cirrhosis after specia evaluation (TB). For liver discase associated with HBV or HCV infection, sce Seotions 10.5.2 and 10.5.3 16.7.4: We recommend screening for hepatocellu- lar carcinoma in candidates with cithosis prior to transplantation using techniques (eg, ultrasound, alphs-eroprotein) and fe quency as per local guidelines (1). (Same as Ree I1.14). SECTION 17: HEMATOLOGIC DISORDERS 17.1: We recommend not routinely screening for throm- bophilia in candidates (1C). T7.1.A:We suggest screening for thrombophilia only in candidates who have experienced a venous thromboembolic event, recurrent arteriovenous access thromboses, non-ath- crosclerotic arterial thrombosis, or family history of venous thromboembolism 10 identify candidates at higher risk of graft thrombosis (2C 17.2:We suggest testing for antiphospholipid antibod- ics (APLAs) in patients with systemic lupus erythe- ‘matosus or features of antiphospholipid syndrome (APS) 2c) 17.3:Candidates should not be excluded from consid- eration for kidney transplantation because of their need for anticoagulation, antiplatelet therapy or a history of HIT (Not Graded). [same as Rec 74] 17.3.1:Single antiplatelet agents (cg, aspirin, clopi- ddogrcl, ticagrelor) can be continued while ‘waiting for deceased donor transplant (Not Graded). [same as Rec 7.4.1] 17.3.2:Delay transplantation for the mandated period of treatment with dual antiplatelet therapy (eg, aspirin plus clopidogrel) when the risk of stopping medication (eg, stent thrombosis) or operating while on treat- ment (eg, surgical bleeding) exceeds the anticipated benefit of transplantation (Not Graded). [same as Ree 7.4.2} 17.3.2.1:Antiplatelet agents (except aspirin) ‘should be stopped $ days prior t0 living donor transplantation (unless cessation is contraindicated) and during the perioperative period for deceased donor transplantation (Not Graded). [same as Ree. 74.2.1] 17.3.3:Do not transplant patients on dieet-acting oral anticoagulants (DOACS; eg, apixaban, rivaroxaban) except when there is specific expertise using DOACS perioperatively and access to DOAC reversal agents (Not Graded). [same as Ree 74.3] 1733.1 Switch to an. alternative anticoag- fant (eg warfarin) prior to wai ing or living donor transplantation if recommended by a thrombosis expertihematologist or if there is no expertise using DOACs periop- cratively or access to DOAC reversal agents (Not Graded). [same as Rec. TAS gents for periop- erative anticoagulation in candidates with a history of HIT (Not Graded). [same as Rec. 7.4.4] 17.4:Eyaluate teansplant suitability of patients with significant cytopenias based on cause and severity (Not Graded) 17.5: We recommend that candidates with sickle cell dis- ‘ease or thalassemia not be excluded from kidney ‘teansplantation [sce sections on cccurrent disease: Section 9.19: sickle cell disease]. (IC) 17.6 Monoclonal gammopathy of undetermined signifi- cance (MGUS) 17.6.1: We suggest not excluding candidates with MGUS from kidney transplantations however, a higher risk of posttransplant Iymphoproliferative disease and other hematological malignancies should be considered and discussed with candidates 2D). 17.6.2: We suggest not excluding candidates with smouldering multiple myeloma from kidney transplantations however, a significant risk of transformation into multiple myeloma should be considered and discussed with candidates @D). 17.6.3:We recommend careful evaluation of ‘candidates. with MGUS for other types of plasma cell disorders prior to kidney transplantation (1D). 17,7 Acute leukemia and high-grade lymphoma, includ- ing posttransplant Ihimphoproliferaive, disease (Same as Section 1.3.1) i iad 17.7.1 Avoid transplanting. patients with leuke- tia of lymphoma und they have received therapy, achieved re ined cancer free for a period t0 be determined in consultation with the patient, a hematologist/oncologist and the transplant program (Not Graded). 17.8 Myclodysplasias, chronic leukemia and chronic/ low-grade lymphoma (Same as Scetion 11.3.2) 17.81:Decisions about kidney. transplantation in patients with myclodysplasia should be ‘made in collaboration with a hematologist (Not Graded). 17.8.2:Advise consultation with a hematologist with transplant experience in determining, transplant candidacy since many lesions may be decred to be at high risk of accel teansplint (Not Graded). m‘$22 Transplantation Ape 2020 a Volume 108 a Number aS 178 Decisions about kidney transplantation in patients with a ptior history of hemrological malignancy Who are now in remission should be made in col laboration with a hematologist (Not Graded) (Same as Ree 11.3.3) SECTION 18: BONE AND MINERAL METABOLISM 18.1; Measure serum parathyroid hormone (PTH) at the time of transplant evaluation (Not Graded). 18.2: We suggest not transplanting, patients with severe hyperparathyroidism until they are adequately treated (medically or surgically) as per KDIGO Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) guideline (2D). 18.3: Bone mineral density (BMD) should not be meas- tured as part of the transplant evaluation (Not Graded). SECTION 19: IMMUNOLOGICAL ASSESSMENT 19.1: Communicate all sensitizing events (eg, blood product transfusion, including platelets, pregnancy Or miscarriage) or clinical events that can impact panel reactive antibody (PRA) (eg, vaccination, withdrawal of immunosuppresiony transplant nephrectomy, significant infection) to the human leukocyte antigen (HLA) laboratory (Not Graded). 192: Perform HLA antibody testing at transplant evalu- ation, at regular intervals prior to transph and aficr a sensitizing event or a clinical e can impact PRA (Not Graded). 19.3: We recommend that HLA antibody resting be per- formed using solid phase assays (1B). 19.4:We recommend HLA typing of candidates at evaluation using molecular methods, optimally at all loci (1D). 19.5: We suggest not routinely testing candidates for non-HLA antibodies (2G). 19.6: We suggest not routinely testing candidates for complement-binding HLA antibodies (20). 19.7:We suggest informing candidates about their access £0 transplantation based on blood type and. histocompati 19.7.1: We recommend offering candidates. with jcally-reduced access to trans: plant access to a larger deceased donor pool, kidney exchange progeams, and/or desensitization (1C). 19,7.2:We suggest that antibody avoidance (eg, kidney exchange programs or deceased donor acceptable mismatch allocation) be considered before desensitization (20). METHODS FOR GUIDELINE DEVELOPMENT aM The overall aim of this project was to develop an ¢ sdence-based clinical practice guideline for the management ‘of patients being evaluated for kidney transplantation. The guideline consists of recommendation statements, ration- ale text, and a summary of systematically generated evi- dence on relevant pre-defined clinical topics. The general gmideline development method is described below. vrwarearsplanjoumal.com OVERVIEW OF PROCESS ‘The development process for the KDIGO 2020 Clinical Practice Guideline on the Evaluation and Management of Candidates for Kidney Transplantation included the fol- lowing steps: ‘+ Appointing Work Group members and the evidence review ream (ERT) += Discussing process, methods, and results Developing and refining topics . [entying population interventions or predictors, and Selecting topics for systematic evidence review Standardizing quality assessment methodology Developing and implementing literatuce scarch strategies Screening abstracts and retrieving full-text articles on the basis of pre-defined cligibility criteria, Creating data extraction forms ‘+ Extracting data and performing critical appraisal of the literature ‘+ Grading the methodology and outcomes in individual studies ‘+ Tabulating data from individual studies into summary Gang quality of evidence for each * Grading quality of evidence for cach outcome across Stiien ‘and asessing the overall quality of evidence across outcomes with the aid of evidence profiles ‘+ Grading the strength of recommendations on the basis, of the quality of evidence and other considerations + Finalizing guideline recommendations and supporting ne draft for public review in October he guiding Publishing the final version ofthe pidline ‘The overall process for conducting the systematic reviews and developing the clinical practice guideline follow international standards, inclucing those from the Institute of Medicine (now known as Health and Medicine Division, National Academies of Sciences, United States usp. ‘The Work Group Co-Chairs and ERT met for a 1wo- day mecting to review the guideline development process, evidence review topics, and systematic review findin Following this, the Work Group, ERT, and KDIGO sup post staff met for two separate mectings to review the available evidence, formulate recommendation statements, evaluate the quality of the evidence and strengsh of ee: ‘ommendations, deliberate on zationale for recommenda. tions, and develop consensus. The draft clinical pra guideline underwent public review, after which revisions to recommendations and text were made where appropriate. Commissioning of Work Group and ERT ‘The KDIGO Co-Chairs appointed the Work Group Co-Chairs, who then assembled the Work Group of domain, experts, inchnding individuals with expertise in adult and pediatric nephrology, transplant nephrology, transplanta- tion surgery, transplantation medicine, transplant immu- nology, and cancer epidemiology. The Brown University Center for Evidence Synthesis in Health in Providence, Rhode Island, USA, was contracted as the ERT to con- duct systematic evidence review and provide expertise in guideline development methodology."The ERT consisted of(© 2020 Weters Kiwer physician-methodologists and experienced research asso- ciates with expertise in nephrology and evidence-based clinical practice guideline development, Defining scope and topics The Work Group Co-Chairs and the ERT defined the overall scope and goals of the guideline including lists of populations, interventions, predictors, comparators, out comes, an! analyses of interest. Together, they then drafted a preliminary list of topics and key clinical questions. The Work Group and the ERT further developed and refined cach topic and specified screening criteria, literature search strategies, and data extraction forms. Establishing the process for guideline development The ERT performed systematic literature scarches and organized abstract and article screening, The ERT also coor- dinated the methodological and analytical processes and. defined and standardized the methodology for performing literature searches, data extraction, and summarizing the evidence. The Work Group took the primary role of writing and grading the recommendation statements and rationale text and retained final responsibility for their content. Formulating questions of interest Questions of interest were formulated according. to the PICOTS criteria (Population, Intervention/Predictor, Comparator, Outcome, Timing, and Study Design). Details of the PICOTS criteria are presented in Table 1 Ranking of outcomes The Work Group ranked outcomes of interest on the basis of their importance for informing clinical decision making (Table 2). Literature searches and article selection Systematic search strategies were developed by the ERT with input from the Work Group Co-Chairs. Modules were created for kidney transplantation, study designs, and terms for cach of the systematic review topics. Separate scarches were conducted for cach topic (or scts of related topics). Searches were conducted in Medline (via PubMed), EMBASE, Cochrane Central Register of Controlled ‘Trias, and Cochrane Database of Systematic Reviews. No date or language restrictions wereentered into the searches. The Full literature search strategies are provided in the Supplemental Appendix: A. The final scarches were conducted in August 2017. The search for gammopathies was conducted in May 2019, Searches were supplemented by articles provided by ‘Work Group members through September 2019. For selection of studs, all members of the ERT screened each set of abstracts in duplicare using an open-source, on- line screening program Abstracke (htep:/fabstrackrcebm. brown.cdu/). To establish relevance and consensus among, reviewers, the entire team screened and achieved consensus, fon a scries of initial batches of 100 abstracts. A total of 45,914 citations were screened (Figure 1). Journal articles, reporting original data or systematic reviews were selected for evidence review based on a priori criteria for cligible evidence. Of these, 762 were sclected for consideration for inclusion, After review of the fulltext articles, 190 were included, as enumerated in Table 3. Data extraction Data extraction was done by ERT research associates. Extracted data from cach study was reviewed by another ERT member to confirm accuracy. The ERT designed forms to capcure data on design, methodology, eligibility criteria, study participant characteristics, interventions, comparators, predictors, outcomes, and results of indi- vidual studies. Methodology andl outcomes were also sys- tematically assessed for risk of bias (see the section on risk: of bias assessment below) and recorded during the data extraction process. ‘Summary tables Summary tables were developed for cach reviewed topic with eligible studies. Summary tables contain outcomes of terest, relevant population characteristics, description of intervention and comparator (or predictos), results, and quality grading for each outcome. Categorical and con- tinuous outcomes were tabulated separately. ‘Work Group members reviewed and confirmed all sum- mary table data and quality assessments, Summary tables are available at wows kdigo.org, Evidence profiles Evidence profiles were constructed to assess the qual- ity and rccord quality grades and descriptions of effect (or association) for each outcome across studies, as wel as the quality of overall evidence and description of net benefits or harms ofthe intervention o comparator across all outcomes. These profiles aim to make the evidence s thesis process transparent. Decisions in the evidence py files were based on data from the primacy studies listed in corresponding summary tables and on judgments of the ERT and Work Group. Each evidence profile was initially constructed by the ERT and then reviewed, edited, and confiemed by the Work Group and/or Work Group Chairs. ‘The work products ereated by the ERT for summarizing, the evidence base are listed in Table 3, together with the ‘number of included studies. Grading of quality of evidence for outcomes of individual studies Methodological quality (internal validity) refers to the design, conduct, and reporting of outcomes of a clinical study. A previously devised three-level classification system. for quality assessment was used to grade the overall study quality and quality of all relevant outcomes in the study (Table 4). Grading of individual studies was done by one of the reviewers, then confirmed by another, with discrep- ancies discussed in conference. We based the methodological quality of cach study on predefined criteria. For randomized controlled ti- als (RCTs) and other comparative studies, the ERT used the Cochrane risk of bias tool,® which asks about risk of sclection bias, performance bias, detection bias, attrition bias, reporting bias, and other porential biases. For obser- vational studies, we also used sclected questions from the Nowcastle Ottawa Scale about comparability of cohorts,‘$24 Transplantation Ape12020 a Volume 108 a Number aS vrwarearsplanjoumal.com ‘Systematic review topies and screening criteria Glinical outcomes: Transpant vs. continued waitist Population Adult orci efit fr potential Kdney transplant Intervention Kine ranean (now ant, ay don Comparator Conan o wit Key traepbson, clude inde patents oto rarsplant waist ft avating Wansplantaton), Proditrs ‘Age suberours, obesity subgroups, HV, HEN Outcome oval (case, HY or HBV outames a leant Study desgn Mtv (cuts, HEM, any design pedis, HM) Mrimum duration of flou-up None Mri Wot Subjacts 100 fait), Ary (pcs), Prediction model studies Popiaon Received key transplanta lngeegsty or natonal dalatsse or enue, clude mut-organ vanelantaton, Protoss Pre-ranplaniatin (or at tino oftranspian arable oF, albumin, BMI party at ‘etree, S6A or her nuttin mares, malutiton, age (gata at exter), tobaco se, PRA history of cara disease heart disease stausmeasures, diabetes, aorifac esse, abetic peripheral vascular dsease, pulmonary cisesse specific CKD, cancer history, ‘matty indves, substance use dzcrder intelectual deabliy Ecude organ donc factors. Outcome [prec Moray (al cas), ra ares Pretctor-speifc: Marly Cowe speci), cace ecurene, new-osetdabeles Design Fit study or lve), mtb rye Mrimum Wot subjects 100 Pegi dts Latest ercimentin eis in rafter 2007 CKD recurrance aftr transplantation Popustion nay tenglanaion de to known, pest std) causes of CKD Preir Speci cases of C&D uicone KD reaurene after transplantation centage wih rearence) Design Longin Miriam duration of flow up None Main Wot subecs Variable based on peption frequency of spac causes of CKD Prevention of CKD recurrence Popdaton ney venspanaion duo to FSS, HUS, membranous nepvopty or MPGN Inorenon Treatment for CAD ator around tno of rarepntaton, nding plasma exconglasma phere, rmab, ecuenab, mmunoahsepon, end inmunosupyesion xicone ovtaly(acause ga falurefss, GFR, proterura, ecurent disease (biopsy) Design Longin Mrimum duration of flow up None Mrimun Wot subject None Tuberculosis, Popdaton CKO G65 wih active erodes Invention Set cours tubes teniment Comparator Lang typical cours uberis treatment (no compara Outcome ovat (aF-cause and TTB reaction, gall refs Sty deson Longa Min dation of fou sp None Mri Wo Subjects 50 Nephrectomy (or recurent UTI or BK vrs) Popiation (KO 64-65 wth ecuent UT or Knoy tenga rece wih fodling grat due to BK vin Intervention Nephrectomy rao loaf fine) Comparator No nopirectomy (oo comparao) Outcome ovat (aF-couse oa fares, GFR, ecurent Ul or BK nepvopaty Study dson fay Mrimum duration of flow up None Mri Wo Subjects None Continued(© 2020 Weters Kiwer [TABLE 1. (Continucc) i aw Population Irterention (Comparatr Odtcome Sudy design Mnimum duration of follow-up Minimum Mof Subjects Tuberculosis testing Popalaton Ivervention Odtoome Study design Minimum dation of follow-up Minimum Mof Subjects Vaccination Population Intorention Oxtoome Sudy design Minimum duration of folow-yp Minimum Mof Subjects Prostate cancer Popaiaton Intorention Comparatr Oicame Sud design Minimum duration of folow-p Moimun Mof Subjects Cancer, active Ppaition Pretctor Ouicome Sud design Minimum duration of follow-up Minimum W of Subjects ‘Monoclonal gammopathy Population Preictor Outcome Study doin inimon dratn off up Mima Not Sabjects Cancer sreening Popeaton Ienerton scone ‘Study design imum craton flew up Mima Not Sbjects Echocardiography Population Intervention Kine transplant candidates whe receive tansplants HW HW Motalty(l+cause), graft alrefoss, HY and infecticus outcomes, GFR Comparabve (HN vs. HV) None 100 CKD 64-65 who recive teneptants ‘Ay TB est (re-ansplatation) Test performance ceractrsics, Pst-ransplant TB ouleomes pay None 20 (KD 64-65 who rocoive tensolants ‘Vaccination for/wth Poeumovax Premar 13) inluenza, HBV, measles, shingles Immunogenicity, pos raneplant vaccine elecieness (disease incidence) pay None 20 ‘Kine transplant candidate wth non-mtastatic rotate cancer who receive transplants Prostatectomy fat timo of kidney tanspartaton) None needed Motaliyfl-cause), grat alos, prostate cancer outcomes Longitudinal None 10 Kine transplant candidates with known, specific, treated cancer who receive enspints Waite for ansplentaton llr cancer cure treatment Morality fal-cause cancer, grat fares, cancer recurrence Longitudinal None 10 Ane tenspantcandates who receive tansplarts Testing for gammapaties 'MGUS or MGRS (pre rpost Tp, hematlagccutcomes (st Ti) Kidney outcomes (pst rancpan, suv post Tp) Longin Non None Kine tensplant candidates wit ro know canoer vito receive transplants Cancer screening (any cancer, method) Morality fal-cause, cancer, grat falrefos, cancer Longitudina! None 10 Kidney vensplant candidates asymptomatic fer CHF, vaulr disease or other indications for echocrdgraphy who receive transplants Echocaringraphy measures Continued‘$26 Transplantation Ape12020 a Volume 108 at Number aS vrwarearsplanjoumal.com [ TABLE 1. (Continued) | outcome Study design Moimaam duration of folom-p Mnimamn Wot Subjects Cardiac evascularization Population Inierenion Outcome Study design Minimum duration of flown Mnimuan Wot Subs Cerebrovascular disease screening Population Inierention Outcome Study design Main duration of folo-p Maina Wot Subjects Moray (l-cause, crac, graft aivrelos, cari disease, pulmonary hypertension, fet vertcuar function (overall ocategocal, not specific measures) Longituina’ None 100 (adits), any (peas) CKD G5 (is) wth sve CAD who eee tanspanis Caria evszlazaton ovat (a-cause, catia, yt aureoss Longin None “0 (KD 64-65 who receive tansplans Etracranialcerebrovasculr testing (as seeming) Moray (a-cause, carebrovasculr), grat faitrefos, stroke Longituira None 100 ADPKD-related cerebral aneurysm screening Population Intervention Outcome Study design Mnimuan duration of fol Maina Wot Subjects Hepatitis B treatment Population Intervention Outcone Study design Mnimuan duation of folom-p Mnimamn Wot Subjects Perioperative testing, diabetes Population Intervention Outcome Sudy design Mnimaam duration of olom-p Mnimamn Wot Subjects Perioperative testing, thrombophilia Population Intervention Outcome Sudy design Moin duration of folom-p Moimaan Wot Subjects Psychosocial testing Population Intervention utoome soeKO Inracai reuysm sreentest Nota (cause, ctu, stoke nko ney say None fone (CKD G5 (iss) with HAV who receve transplant HOV treatment HAY cure (HBV DNA) Longitudinal None 10 Undergoing key transplantation Diabetes testing (OTT, FBG/FPG, FBG) Pesoperatve complications, NODA, change in perioperative management my None 100 ‘Kidney vansplant candidates or CKD G5 (as) wt history of VTE, recurent AV aooess throm esis, or arterial trombosés, or fay history of VTE Thromborhia tests Matay(a-cause, ombosis-elaed, galt lossfaure, VTE, perioperative complications, changin perioperaine management fay Noo 200 nay tenepant canddstes ho rose wansparts Psychosocial scales/nruments, inclusing: Psychos Assessment of Caeiates for “Tansplntaon (PACT), taf gate Psyhnsoil Assessvent for Tarspant GPA), “TanspntExauaton Rating Scale (TERS) otaiy(acause) gra faurross, acherence Contined(© 2020 Weters Kiwer sar CEw Cr ed) Sty cosign Longin nium dation of foto any Nirimum Not Sbjct 10 ‘otransplantation with history of nonadhorence Population ‘History of graft fallurevioss due to nonadherence biervetion Ftranspntaton Comparator None necessary ‘Outeome “Mortality (all cause), graft faturess Desig Legis Aénirum draten of flow None ‘Mnium Wof subpots 100 Chest CT Population ‘CKD 64-65, ‘rervention Loweracation chest CT Outcome Mray al aus, ng eanca), ng carcer agnosis Sudy design ay inium draton of folow-p any ‘Moirum Wof Subjects 10 Dual antiplatelet agents Population idee ransplan canddetes who recov tanslats siervention ua antiplattet tetment Comparator Single atpatletreatment ‘Outcome Perioperative complications, Thombosis outcomes ‘Sudy design ‘Comparative ininum dation of fotow-up None imum Mo Subjects ‘lam yperparathyroidism Population ‘Kidney transplant candidates who receive tansplants with hyperparathyroidism (with or withc hypercalcemia) bervetion Parathyidectomy ‘Comparator ‘No surgery (or no comparator) ‘Outeome ‘Mortality (all-cause), graft failure/loss, parathyroidectomy post-transplant Say design Any Aénirum duration of flow None rium Mot Subjects 2 Peripheral artery disease testing Population CKD 64-G5 with clinically apparent PAD who receive transplant ‘ervenion Peripheral artery seas testing Outeome Perioperative camplicaions, Change in management, PAD post-transplantation | ‘Study design: Any rium duration of flow-up Any ‘Moirum of Subjects 10 ‘07D, awosraldoniar poe ey doe A eee BM nas redex cy ay dee CF geste ea ae OO cenit zs compte ‘Era cOF, erat Gamer fr FAG erg needs ghcoay FSS alsin umacecoee GF, gorau rina epateB cen (eye hr ret) et, HS ht ean OS, te psy ol are GB, mac Ardsmtet ont MGR ertrnnolizva rer ep HAT, ew rt obese ameter OT ta ta Wes et PD pre ey lado aod AS, ns bbe pa SA nbc ght aes fun assert, abort Thay tac ar, VTE yrus nee. Hierarchy of outcomes irarhy Outcome Cita importance ‘ori, grafts, rracranal aneurysm ptr, stroke igh importance | Graft os (caus pectic), caroa, infection, ntacrarial aneurysm, uncon recurent kidney disease Moderate importance NODAT, noradherence, uncimpkcated UT De enna NODA, ew ast dee afar napraon Una tac in‘$28 Transplantation Ape12020 a Volume 108 at Number aS FIGURE 4. Search yidd, ‘See Table 3 for enumeration by topic vrwarearsplanjoumal.com representativeness of the population, and adjustment for different lengths of follow-up.” Based on these characteris- tics an overall assessment was made whether the study was of good, far, or poor quality (Table 4) Each reported outcome was then evaluated and given an individual grade depending on the quality of report- ing and methodological issues specific 10 that outcome. However, the quality grade of an individual outcome could not exceed the quality geade for the overall study. Grading the quality of evidence and the strength of a guideline recommendation A> structured approach, based on ‘Grades of Recommendation, Assessment, Development and Evaluation’ (GRADE)*"" and facilitated by the use of evi- dence profiles was used to grade the quality of the over- all evidence and the strength of recommendations. For cach topic, the discussion on grading of the quality of the i overs or tw giceie ms a i eae eye ee 11, Aooess to Transplantation | Tap vs. WL 1832 8 + nee . . 2Agasatate : : : : 3. Pediatric issues. t t + ‘Popol ees Patt us ! Shes same wonihern 1s ‘ : Store anon ir : : 7 Oheiyanldotanaiaes fae a H : eae ray 7 i : Stat emece 28 % : meus i 0 : tn ectin nn es t : ‘Nephrectomy: 1528 a + is 5 t 2 3 : — 20 3 11. Malignancy ‘Cancer Tx 1001 2 h Panam a 3 : Sree ~ i : 12 nae oe cot 2 } : ord ee ma sat 2 : oe met é : 14. Peripheral artery disease PAD 1400 0 me te Nerooge dons fore ae ‘ : ‘Carotid Doppler 988 1 + 18 a or doans : 0 : Tr eng tres Tron Ps 8 z bait os } : ee ts 2 & 18 inoardninalnsttsion Pl on : inatkieteg Cesena ine 3 - passant ae 2 8 : CPA, ane cries dese an, ab rns Ome comm Ch eanpued meagan econ SMD oes ny dene Og sth HE st Bi Fran smut us HA han bkoofe as, eel dbese Pi, produ Re. eve Rese ‘waszria, TE bss Th tet. rangi cca al ects WL wali. "opeswee ce yates ot gs se | Coeradwehn ath pe sexes an ules(© 2020 Weters Kiwer one Classification of study quality Good quality must be RT. Fair quality prospect. Poor quality orrevospectve. Low risk bias andno obvious reporting eros; complete reporting of dala. Must be prospective. study of intervention, Moderate risk of bas, ut prblems with study or paper are unkly to cause major bas. study of rtevention, must be High rik of bias or cannot rue out posse sgticant biases, Poor methods, incomplete dat, reporing errs. Prospective Fete contd GRADE system for grading quality of evidence Stop Starting arede for ‘quality of evidence based on study design Randomized vials = High Stop 2: Reduce grad ‘Study qulty 1 lev if serious Iimilations ~2 level if very serous limitations (Observational study = Low Consistency level it mportant ‘noansistoncy ‘ay ther evidence = Very Low Direcness—1 lve if some uncertainty ~2levesif major uncertainty Strength of association +1 level if song plausible cofanders ove ry ono maj thes toaty Other +1 elf evidonce ofa o2-reaponse gradient +1 veil esa plausible Final grade for quail of evidence Stop 2: faze grade ‘nd dition High = Further research i unikely to change confidence in the estimate of eect, Moderate = Further research is tkely to have an important impact on canfidence in the estmatoof ct, and may change the estimate Low = Furter research is very key to have an important impact on confounders would have reduced _onfidancein tho estima, and may Oher—| vet sparse or imprecise the observed effect. change the estimate ata’ —1 level high prbabity of Very Low = Any estimate of effects reporting bias very uncertain G0E,Gngct Recarmerne Asmar Doeopret and lute peg tse aan ee ya an at = (based on coset acs rom tor ae erate tig ah mo lal cn Day spect seins reagent act hn mp reso iy pre ober sy a Ft W800 peda Te hao na ee Weer sm Cra Mal ping age > Atay priser, Mant Craigs a al evidence was led by the ERT, and the discussion eqgarding the strength of the recommendations was led by the Work Group Co-Chairs. The “strength of a recommendation” indicates the extent to which one can be confident that adherence to the recommendation will do more good than harm. The “quality of a body of evidence” refers to the extent to which our confidence in an estimate of effect is sufficient to support a particular recommendation.” Grading the quality of evidence for each outcome across studies. Following GRADE, the quality of a body of, 1g 0 a particular outcome of interest was ly categorized on the basis of study design. For each outcome, the potential grade for the quality of evidence for each intervention-ourcome pair started at “high” but was then lowered if there were serious limitations to the methodological quality of the aggregate of studies, if there were important inconsistencies in the results across stud- there was uncertainty about the dircctness of evi dence including limited applicability of the findings to the population of interest, if the data were imprecise (a low event rate [0 or I event] in either arm or a confidence interval [Cl] spanning a range both <0.5 and >2) or sparse (only 1 study o total N ¢ 500), oF if there was thought to be a high likelihood of bias. The final grade for the qual- ity of the evidence for an intervention-outcome pair could be one of the following four grades: “High”, “Moderate”, “Low” or “Very Low” (Table 5) Grading the overall quality of evidence. The quality of the overall body of evidence was then determined on the basis of the quality grades for all outcomes of interest, taking into account explicit judgments about the relative sportance of each outeome. The resulting four final cate egories for the quality of overall evidence were: “A”, “B", *C* or “D” (Table 6). “Assessment of the net health benefit across all important clinical outcomes. The net health benefit was determined oon the basis of the anticipated balance of benefits and harms across all clinically important outcomes (Table 7). ‘The assessment of net benefit also involved the judgment of the Work Group and the ERT. Developing the recommendations. Draft recommen dation statements were developed by the Work Group Co-Chairs and Work Group members. The health benefits, side effects, and risks associated with cach recommenda tion were considered when formulating, the guideline, as, well as information on patient preferences when available.‘$90 Transplantation a Ape 2020 a Volume 108 at Number aS vrwarearsplanjoumal.com TABLE Final grade for overall quality of evidence Grade Qual of Evidence Meaning A High Wie ae confident thatthe tre effect lies clase to that ofthe estate ofthe ofc. Bo Noderate ‘The tue effets Haly tobe closet feestinate ofthe elec, bu here is @ possibilty that tis substantaly ferent © low ‘The tru efect may be substantial diferent from the estimate ofthe effect. D_Veylow ‘The estimate of effect is very uncertsn, and often wl bo far from the tut [Aste 7, Balance of benefits and harms \When thee was evienca to determine the balance of medical bones ‘and harms of an intervention to patient conclusions were categorized ax folows * For staisticaly sigficant benef arharm, pet as “benefit or harm) of iterventon’ + Fornon-stasticaly siiicant boneft harm, report as “posi benefit for har] of intervenor” * In instances whore sts ar ncorisent, reports possible benoit [or har] of intervention’. "No ference” can orl be reported fa study snot imprecise. + “euificint evidence” i reprtedifimprociscn isa fcr. Recommendation statements were revised in a multi-step process during face-to-face meetings and by subsequent drafts by email. All Work Group members provided feed- back on initial and final deafts of the recommendation. A draft was then distributed for external public review and subsequently revised by the Work Group Co-Chairs and members based on this open feedback. Approval from all ‘Work Group members must be received before publication of the final guideline. Grading the strength of the recommendations. The strength of a recommendation is graded as level 1 oF level 2. Table & shows the KDIGO nomenclature for grading the strength of a recommendation and the implications of cach level for patients, clinicians, and policy maker Recommendations can be for or against doing, something. Each recommendation includes an explicit link between the quality of the available evidence and the strength of that recommendation. However, Table 9 shows that the strength of a recommendation is determined not only by Per the quality of the evidence but also by other, often com- plex judgments regarding the size of the net medical ben- efit (potential risks vs. benefit, values, and preferences, and costs. Formal decision analyses including cost analysi were not conducted. Ungraded statements. This category was designed to allow the Work Group to issue general advice. Typically an ungraded statement meets the following criteria: it provides guidance based on common sense; it provides reminders of the obviouss and it is not sufficiently specific to allow for application of evidence to the issue and there fore it is not based on systematic evidence review. As such, ungraded statements may be considered to be ¢clatively strong recommendations; they should not be interpreted as, ‘weak recommendations based on limited or poor evidence. Common examples inchide recommendations about fre- quency of testing, referral to specialists, and routine medical care, We strove to minimize the use of ungraded recommendations. grading scheme, with two levels for the strength of a recommendation together with four levels of grad ing the quality of the evidence, as well as the option of an ungraded statement for general guidance, was adopted by the KDIGO Board in December 2008. The Work Group took on the primacy role of writing the recommendations and rationale statements and retained final responsibility for the content of the guideline statements and the accom panying narrative. The ERT ceviewed draft recommenda tions and grades for consistency with the conclusions of the evidence review. Format for guideline recommendations. Each topic section contains one oF more specific recommendations. Within each recommendation, the strength of recommen- dation is indicated as level 1 or level 2 and the quality of KDIGO nomenclature and description for grading recommendations Grade Implications Pa ‘lic Policy Level t ‘Most poopleinyourstution would Moct patios should reve therecom- The recommensaton can be evaluated as ‘Werecommend” want te recommended course of mended couse of action. ‘a candi for developing policy of a action and erly a small proportion performance measure. ‘wouldnt Level 2 ‘The mejriyof people inyoursius- Dien choices willbe appropriate or The recommendation is kel to require ‘We suggest" tion would wart the recommended different patents. Each patient noeds substantial debate ard iwolvment of ‘curse of action, but mary woul nat hop toartve at a management dec ‘Son consistent with her or his values and preferences. stakeholders before plcy canbe deter mined, “The abr cap Tet Gada wel palo prof plince aod ce cman rename ttc oer aw sgn atk wee Teme cannon eae ‘de ecco rey ott els cuted andes ober ial specs Unga sarcomere rae sass ‘er neutn be ripen a acy sera eaves ten ae 2 onentie(© 2020 Weters Kiwer the supporting evidence is shown as A, B, C, oF D.The ree Commendation statements and grades are followed by the rationale text summarizing the key points of the evidence base and the judgments supporting the recommendation. In relevant sections, considerations of the guideline state- ‘ments in international settings and suggested audit eriteria are also provided where applicable. Important key points and rescarch recommendations suggesting future research Deteminants of sength of recemmendtion = a Aieesteen Gahaiand Te ga tx domcsbeieo tie dele ad uniiniocice Bere ical ecm undesirable effects: is warranted. The narrower the gradient, the more likely a level 2 recommendation is warranted. Quality of the evidence: ‘The higher the quality of evidence, the more likely a level 1 recomimendation is warranted. ecganss §— sepereiy esanendimastenge ars tcaaiy eles alpaca roc Costs resource aloaton) ‘akvel2 recommendations werrated, Values and preferences were claned from the trate where pos sible or wee assessed inthe judgment ofthe Work Crcup when robust evidence was not identi The higher the coss of an ntavention—tal is, the more resources consumed—the less key aleve 1 recom: ‘mandation is warranted, ‘The Conference on Guideline Standardization (COGS) checklist for reporting clinical practice guidelines: Tope “Tope Description How Tope Addressed ‘Overview material ‘Provide asvuctuedabsvact that ines the uide-__Atsact ard Execute Suny 2. Focus 3.Goal 4.User/setting 5. Target population 6. Developer 7, Funding source/sponsor 8 Evidence collection line's ress dat, tats (gna ese updated), an print are eactroicsoures. Describe the primary dseasefconon ad interven fonerviotectnoiogy hat the quidine dros. Iaicate any alterratve presntatve, dagnasicor therapeatic nervenns that wee considered ring doelopnent Desert the gol hat folowing the guideline is expected ‘ache inducing the atonal fr development of a iene on tis op Desrise the intended uses ofthe guideline eg, provider types, pains) andthe sotings in wich the guidelines intended tobe used. Desi the pant population lil for guideline recommendations and ist ary exclusion critra, Went fhe organizations) response for guidetne development andthe nanes/credentak/potentil conflicts of tres of individuals iwoed inthe guidelne’s cevelopmert. Identity te funding sourcelsponsor and describe its role in deveing andor reortng the quidsine. Disclose petra confit of interest. Describe the method use to search the scintic tera, notuting the range of dates ard databases searched, and citra applied oft the retived cendence. ESKD, canditates for kidney transplantation. tere tions and teatmenis to assess candidacy and prepare candidates fr transpattaton This OP intended to assist the practitioner caring for ations with CKD wio are potential candidates for trarspantton, with the particular goa of minimizing raf loss anc death while opfimizing patents’ quality off Target audience is practcng nephrolgits and other heath care providers fr adls and chicken wit ESKD who are potertialcanedstes for transplantation ‘chit and ciliren with SAD vio ae potential cand dates fr raneplntation Organization: KDIGO Nameslredentals/potetal coi of tre af Work Group members ined inthe quienes develo ment are dsclosedin the Aopen: Biographic and Disclosure tomation. This guider fs unied by KOGD. Toes were waged ether to ) systematic rv t) sjstematc search folowed by nerate summary, or c)narave summary. Fer systematic eviews, We searthed Publed, EMBASE, Coctrane Ceiral Reg. ‘sry for as, and Coctrane database of systematic reviews. Screening era fortis and other topics are ould in the Methods for Guetne Develon- ‘ment ection. The search was updated trough ‘August 2017, with an addtioral search conducted in May 2019 and supplemented by ates identified by Work Groyp members through September 2019, We also searched for pertinent exsing quifelins and systematic ravens. Continued next page‘$82 Transplantation a Ape12020 a Volume 108 at Number aS vrwarearsplanjoumal.com [TABLE 10. (Continued) | Tepe ‘Topic Description How Topic Addressed 9. Recommendation Desatbe the ceria usedto rate the qual of evidence Quality of indidual studies was graded ina tree-Hered grading criteria that suppers te recommendations andthe tem radng sytem (oe Table 4). Qual of evidence ard {or descr the strength ofthe recarmmends strength of recommendations were graded fling tion Recommendation sergth communicates the the GRADE appreach (Tle 6 and 8). The Werk Importance of adherence toa recommendation and Group ood provid general guidance inthe frm of ‘based on bot the qual of the evidence and the ungraded slalement, rmagrtude of anicigated benefits and harms. 10, Method for Describe how evience was used tocrealerecommen- Far systematic review topics, summary tables and symhesizing evidence sions, eg, evden lables, mol-enaljss, decision __evilence pots were generale. Forreoommenda- 11, Prereloase review 42. Update plan 18, Definitions 14, Recommendations and rationale 15, Potential benefits and 416, Patient preferences 17. Algorithm: 18, Implementation considerations analy. Describe how the guideline develope eve andlor {ested the quienes prior to release. ‘Stato whether or not there isa plan to update he guideline and, if applicable, an expraton date fr this version of the guideline. Define unfair terms and those crcl to correct. ‘applcatienof the guideline tht might be subject to msinterprtatin, ‘State the recommended acon precisely andthe spectic ‘crcumstancss under which fp perform it sty each recommendation by descriing te Enkage between the recommendation andits supporting evidence. Incicate the quay of evidence and the recommen dation strengih, based on the ctiteria described in Topic 9 Desctibe anticipated benefis and pte sks assoc- ‘ated wth implementation of guideline recommenda ies, Describe the role of patent preferences when arecom- ‘mervation imohes a susan element of personal choice o values Provide (ten appropri) agape descripion of the stages ard decsons in ical care described y the aideine. Describe anticipated bares to application fhe rc commendations, Provide reference any auary dbeuments fr provides or patents ta intended {o facia implementation. Suggest evi ereria foc mzsung changes in care wren te guidlines implemented tions on interventions, the step outined by GRADE were followed. The guide has undergone extral publ review in October 2018, Pub review comments were Comin fed backt the Werk Group, which considered comments nits evson of the quidlne. Following the publication ofthis gael, requirement {or updating wil be assessed on a regular basis to etermine fnew evidence wil lead to changes tothe recommerdations or may mody information posited bein ‘See Abbreviations and Acronyms, Each guideine section contains recommendatiors for the management of potential kidney transpanta- ‘ion candidates, Each recommendation tlds on supporting rationale wit evidence tales if avaiable The stengh ofthe recommendation and the quay of evidence are provided in parenthesis win 2ach recommerdatin, The benefits and harm foreach compaiso of even tions are prone in summary tables and surnmared inevidence groies. The estimated tatance between potent benefts and harm was considered when formulating the recommendations, Recommendations tat are love 2 o "isretionary.” Indicating a greeter need to help each paint arta ata management decision consistent with hero his ‘ales and prferencos. ‘See Figures 2 and 3. ‘These recommendlions ae global. Lcal versions ofthe guideline are anticpate to facitate implementation and approprat care, Review citer were not sug (sted because implementation with priontization and development of reion criteria have to proceed local Most recommendations are discretionary, requiring substantia discussion amang stakeholders before they can be adopted as review tera. The decison \whether to convert any recommendations to review cate wil vary lobally Research recommendations were also cutind to adress curent gaps inthe ev- ence base (0, cnc korea: 6 cn pace gene ESD, ensign see; GRADE, Gago Fanentatins sme, Deer rd Ges KD Kihey Dae pry Gb Duos