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

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This exploratory, randomized, double-blind, placebo-controlled, multicenter, proof of concept, Phase 2a study will evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of orally administered GLPG2737, for a treatment period of 52 weeks, in participants with rapidly progressing ADPKD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galapagos NV

Criteria

Key Inclusion Criteria:

• Documented diagnosis of typical ADPKD, using the Ravine criteria (Ravine, et al., 1994).

• Rapidly progressive disease, defined as presence of all of the following:

• Total Kidney Volume (TKV) >750 mL, as determined on imaging not older than 5 years before screening. If historical imaging is not available or older than 5 years, imaging can be performed during the screening period according to local clinical practice (that is, echography, magnetic resonance imaging [MRI])

• Mayo ADPKD Classification Classes 1C to 1E.

• eGFR at screening between 30 to 90 mL/min/1.73 m^2 for participants aged 18 to 40 years (inclusive), and between 30 to 60 mL/min/1.73 m^2 for participants aged 40 to 50 years.

• Blood pressure ≤ 150/90 mmHg. In case a participant is treated for hypertension, she/he should be on a stable treatment regimen of antihypertensive therapy for at least 8 weeks prior to the screening visit, and during the screening period.

Key Exclusion Criteria:

• Congenital absence of 1 kidney, or participant had a previous nephrectomy or has a transplanted kidney or a transplantation is planned in the foreseeable future.

• Administration of polycystic kidney disease-modifying agents (for example, tolvaptan) or interventions (such as cyst aspiration or cyst fenestration) within 12 weeks prior to the screening visit and during the screening period. In case tolvaptan is not being administered, this should be because of e.g. non-availability, intolerance, or physician's clinical judgment.

• Any condition or circumstances that, in the opinion of the investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements (for example, unable to undergo MRI due to participant's weight exceeds the weight capacity of the MRI, ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, etc.).

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.