Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD
Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD
Brief Summary:
The goal of the study is to compare and evaluate safety and efficacy of tesevatinib 50mg versus placebo in patients with ADPKD.
Detailed Description:
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.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Randomized Parallel Group Study of the Efficacy and Safety of Tesevatinib in Subjects With Autosomal Dominant Polycystic Kidney Disease
Actual Study Start Date: August 9, 2017
Estimated Primary Completion Date: January 31, 2022
Estimated Study Completion Date: January 31, 2022
Arm:
- Experimental: Treatment Group
- Placebo Comparator: Control Group
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Actual enrolment | 80 |
| Actual Study start date | 09 August 2017 |
| Estimated Study Completion Date | 31 January 2022 |