A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects with Autosomal Dominant Polycystic Kidney Disease
Brief description of study
This is a Phase 2b, multicenter, double-blind, randomized, parallel group study to evaluate the change in total kidney volume as measured by MRI in subjects with ADPKD treated with
tesevatinib or placebo. We are enrolling male and female subjects with ADPKD, 18 to 60 years of age and with minimal to moderate kidney disease. Up to 100 male and female subjects will be randomized 1:1 to receive 50 mg of tesevatinib QD or placebo.
Detailed description of study
Subjects will be screened up to 28 days before initiation of treatment with tesevatinib in order to determine eligibility. Starting on Day 1, subjects will receive 50 mg QD of tesevatinib or placebo for up to 24 months. Entry into the study will be based on local MRI readings, but central MRI readings will be performed at baseline and during the study. In addition, Participants will get echocardiograms, EKG's, eye exams, and blood and urine testing as part of the study.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
Polycystic kidney disease,Mitral Valve Insufficiency,,mitral valve insufficiency
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Age: Between 18 Years - 99 Years
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Gender: All
Updated on
10 Jul 2023.
Study ID: 828819