Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD
Diseases of the Kidney & Urinary Tract
What is the purpose of this trial?
Safety and efficacy of 50mg tesevatinib in comparison to placebo in patients with autosomal dominant polycystic kidney disease (ADPKD) will be assessed.
The primary purpose of this study is focused on evaluating the change from baseline in height-adjusted total kidney volume (htTKV) as measured by magnetic resonance imaging (MRI) at Months 12, 18, and 24 in patients with ADPKD treated with tesevatinib or placebo.
If eligible for the study participation, subjects will be randomly assigned to either investigational treatment group or placebo group. Treatment group will receive 50mg tesevatinib once daily for 24 months and control group will receive the placebo once daily for 24 months.
- Ages18 - 60 years
- Trial withKadmon Corporation, LLC
- Start Date02/26/2018
- End Date06/29/2020
- Last Updated08/20/2018
- Study HIC#2000021472