Tesevatinib in Subjects with Autosomal Dominant Polycystic Kidney Disease

Disease

Autosomal Dominant Polycystic Kidney Disease

Protocol Title

A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects with Autosomal Dominant Polycystic Kidney Disease

Principal Investigator and Contact Information

Irina Barash, M.D., M.S.
Phone Number: 212-746-7647
E-mail: [email protected]

Enrollment Status

Open to Enrollment

Brief Summary of Protocol

The purpose of this study is to learn if tesevatinib, an investigational drug (not approved by the Food and Drug Administration), is a safe and effective treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD). Tesevatinib blocks a protein, called Src kinase, and may slow down or stop uncontrolled growth of kidney cells as a potential treatment of ADPKD.

To be eligible to participate in the study, a candidate must be between 18 and 60 years old and have a confirmed diagnosis of ADPKD. Additional eligibility criteria will be reviewed when volunteers contact the study team.

The study consists of a screening period, a treatment period, and a final visit. Participants will be randomized (assigned randomly, like flipping a coin), into one of two possible study treatment groups to receive either tesevatinib or placebo (inactive substance). Neither the participant nor the study staff will know if the participant is receiving study drug or placebo. Participation will last approximately 2 years and 3 months and will include approximately 23 visits to The Rogosin Institute.

Physical exams, vital signs, blood and urine tests, electrocardiograms will be performed at most of the study visits, and echocardiograms, magnetic resonance imaging (MRIs) scans (without any dye) and eye exams will be performed at some of the visits. Participants will receive a study stipend, and most transportation expenses will be reimbursed.

Potential Benefits

There is no guarantee that participants will receive direct benefits from this study. However, information gained from this study will help doctors learn more about tesevatinib as a possible new treatment for ADPKD and could help future patients.

Sponsor Information

Kadmon Corporation, LLC

Protocol Number

KD019-211

Institutional Review Board (IRB)

Western IRB
ClinicalTrials.gov
Identifier: NCT03203642