NCT03203642

Study of the Efficacy and Safety of Tesevatinib in Subjects With ADPKD

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Kadmon, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of the study was to compare and evaluate safety and efficacy of tesevatinib 50 milligrams (mg) versus placebo in participants with autosomal dominant polycystic kidney disease (ADPKD).

Detailed description

Safety and efficacy of 50 mg tesevatinib in comparison to placebo in participants with ADPKD was assessed. The primary purpose of this study was 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, and 30 days post-dose in participants with ADPKD treated with tesevatinib or placebo. If eligible for the study participation, participants were randomly assigned to either investigational treatment group or placebo group. Treatment group received 50 mg tesevatinib once daily for 24 months and control group received the placebo once daily for 24 months.

Conditions

• Autosomal Dominant Polycystic Kidney
• ADPKD

Interventions

Type	Name	Description
DRUG	Tesevatinib	Pharmaceutical form: Tablet; Route of administration: orally
DRUG	Placebo	Pharmaceutical form: Tablet (identical to tesevatinib); Route of administration: orally

Timeline

• Start date: 2017-10-12
• Primary completion: 2022-01-25
• Completion: 2022-01-25
• First posted: 2017-06-29
• Last updated: 2023-02-06
• Results posted: 2023-02-06

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study