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

  • STATUS
    Recruiting
  • End date
    Nov 11, 2022
  • participants needed
    60
  • sponsor
    Galapagos NV
Updated on 11 July 2021

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.

Details
Condition Polycystic Kidney, Autosomal Dominant, autosomal dominant polycystic kidney disease
Treatment Placebo, GLPG2737
Clinical Study IdentifierNCT04578548
SponsorGalapagos NV
Last Modified on11 July 2021

Eligibility

Yes No Not Sure

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

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
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