A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
This is an exploratory, randomized, double-blind, placebo-controlled, parallel group, multicenter, proof of concept study (Phase 2a), evaluating orally administered GLPG2737 for a double-blind (DB) treatment period of 52 weeks and 4 weeks of follow up as well as an open-label extension (OLE) treatment period of 52 weeks and 4 weeks of follow-up, in subjects with rapidly progressing ADPKD.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Orally Administered GLPG2737 for 52 Weeks, Followed by an Open-label Extension Period of 52 Weeks in Subjects With Autosomal Dominant Polycystic Kidney Disease
Actual Study Start Date: November 10, 2020
Estimated Primary Completion Date: January 2023
Estimated Study Completion Date: February 2024
Arm:
- Experimental: DB Period: GLPG2737
- Placebo Comparator: DB Period: Placebo
- Experimental: OLE Period: GLPG2737
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Actual enrolment | 66 |
| Actual Study start date | 10 November 2020 |
| Estimated Study Completion Date | 01 February 2024 |