A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Summary

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 participants with rapidly progressing ADPKD.

Timeline

Start

2020-11-10

Primary completion

2022-12-14

Completion

2023-04-04

Outcome

Missed primary endpoint

Stopped: “The study was early terminated due to lack of efficacy.”

registry analysis (superiority test); GLPG2737 During DB vs Placebo During DB; p = 0.606; Geometric Mean Difference -0.91 (95% CI -4.34 to 2.64) NCT04578548 ↗

Publications

• Results Ron T. Gansevoort et al., 2022. The MANGROVE Phase 2 Trial: Study Design and Baseline Characteristics of Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD). Abstract (385) presented at the Annual Congress of the American Society of Nephrology, 3-Nov-2022 to 6-Nov-2022.
• St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GLPG2737	Small molecule	150 mg	Oral

Indications