Join The ALERT Study today

Let’s make a difference

in Autosomal Dominant
Polycystic Kidney Disease
(ADPKD) research together
Living with ADPKD, a Genetic Disorder
ADPKD is a genetic disorder where the
kidneys develop fluid-filled cysts that, in
time, make the kidneys larger. The disorder
is caused by a mutation of the PKD1 or PKD2
gene, interrupting normal cell activities in
the kidney causing cysts to form and grow.
As cysts grow in the kidney, normal kidney
activities fail, and eventually require dialysis
or a transplant.

The current treatment options for most

ADPKD patients are limited to therapies
that treat the effects of the disorder rather
than the disorder itself. There is a drug that
was approved by the FDA called tolvaptan
or more commonly known as JYNARQUE®
which addresses the disorder. Tolvaptan
(JYNARQUE®) is also approved in other
countries to slow the growth of cysts in
ADPKD patients. However, according to FDA
approved labeling, JYNARQUE® can cause serious
liver problems.

A new form of treatment is needed to

improve the quality of life and better manage
this disorder which is why we are conducting
The ALERT Study.
About Clinical Research
Clinical research studies, also called clinical
trials, look for new ways to prevent, detect,
and treat diseases and illnesses. They are
designed to test the safety and effectiveness
of study drugs to understand if these potential
treatments can be used in the future.

Before a clinical trial can begin to enroll study

participants, the trial must be approved
and monitored by an Institutional Review
Board (IRB), or Ethics Committee (EC), whose
primary purpose is to protect the safety and
rights of all study participants.

All personal information provided by study

participants will be kept confidential and will
never be linked to any person outside of the
study unless required by law.
The ALERT Study: Clinical trial for
the treatment of ADPKD
The ALERT Study is an open-label (no placebo)
study designed to fi nd out how safe the study
drug (lixivaptan) is for ADPKD patients who
were treated with tolvaptan (JYNARQUE®) and
had to stop because of abnormal liver
chemistry test results while on the drug.

The ALERT Study: Lixivaptan,

the study drug
The study drug that is being tested is called
lixivaptan. It’s an oral drug that works by
blocking a receptor in the kidney that is known
to cause cysts in ADPKD patients to grow.
Lixivaptan is in the same drug class and has the same
mechanism of action as tolvaptan.
Adverse effects (AEs) of lixivaptan in past clinical
studies were anticipated from the drug’s
pharmacologic activities, e.g., signs and
symptoms of increased water excretion such as dry
mouth, thirst and frequent urination. Similarly, AEs
noted in the Phase 2 program in ADPKD subjects are
consistent with the pharmacologic effects of the drug.
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To join, you or someone you know must:
 be between the ages of 18 and 65 at the time
of Screening.
 not be pregnant, not be lactating, and not be
actively trying to get pregnant.
 have a confirmed diagnosis of ADPKD by
imaging or genetic (DNA) analysis and have
been previously treated with tolvaptan
(JYNARQUE®) for that diagnosis.
 have permanently stopped taking tolvaptan
(JYNARQUE®) because of abnormal liver
chemistry test results while on it.
 meet other criteria which the study staff
will discuss.
The ALERT Study: What else should I know?
 Taking part in a clinical research study is
optional. Your participation can be withdrawn at
any time for any reason.
 No matter what happens, care by doctors and
nurses will not change.
 Study-related therapies and assessments will be
provided at no cost.
 Reimbursements for reasonable study related
expenses may be provided.

The ALERT Study: Find out more about

the study
To learn more about The ALERT Study and to find
out if you may potentially qualify for the study,
please visit

https://clinicaltrials.gov/ct2/show/NCT041
52837

The study will be explained in more detail and

if it seems to be right for you, next steps can
be discussed.

PA-ADPKD-303_Patient Brochure_V2.0_09Sep2021_Master English