A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Autosomal Dominant Polycystic Kidney Disease
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease
Eligibility Criteria
Key Inclusion Criteria for the double-blind period of the study:
- 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 Inclusion Criteria for the OLE period of the study:
- Male and female subjects who completed the 52-week double-blind treatment period on investigational product (IP).
- Subject, according to the investigator's judgment, may benefit from long-term treatment with GLPG2737.
Key Exclusion Criteria for the double-blind period of the study:
- 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, somatostatin analogues) 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.).
Key exclusion criteria for the OLE period of the study:
- Clinically significant abnormalities detected on 12-lead ECG of either rhythm or conduction, QTcF >450 ms, or long QT syndrome.
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Cliniques Universitaires St. Luc (UCL)
- UZ Leuven
- Fakultni nemocnice u sv. Anny v Brne
- Fakultni nemocnice Hradec Kralove
- Vseobecna fakultni nemocnice v Praze
- Uniklinikum Dresden
- IRCSS Ospedale San Raffaele
- Azienda Ospedaliera Universitaria Federico II
- Uni Campania L. Vanvitelli
- Fondazione Salvatore Maugeri IRCCS
- Amsterdam UMC
- UMCG
- Radboud UMC
- Specjalistyczne Centrum Medyczne SCM Spółka z o.o.
- DaVita Sp. z o.o. Stacja Dializ
- Szpital Kliniczny UM w Lodzi
- Fundacion Puigvert
- Hospital Universitari de Bellvitge
- Nefrologia Clinica C.P.
- Hospital Universitario Dr. Peset
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Experimental
DB Period: GLPG2737
DB Period: Placebo
OLE Period: GLPG2737
GLPG2737 will be administered orally once daily with food for 52 weeks.
Matching placebo will be administered orally once daily with food for 52 weeks.
Participants completing the DB period (GLPG2737 and placebo arm) will enter an OLE period of 52 weeks where GLPG2737 will be administered orally once daily.