A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
- Conditions
- Autosomal Dominant Polycystic Kidney Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT04578548
- Lead Sponsor
- Galapagos NV
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo During DB + GLPG2737 During OLE Placebo Participants received placebo matched to GLPG2737 capsules orally once daily for 52 weeks in the DB treatment period. Eligible participants were rolled over to an OLE period to receive 150 mg GLPG2737 orally once daily for 52 weeks. GLPG2737 During DB + During OLE GLPG2737 Participants received 150 milligrams (mg) GLPG2737 capsules orally once daily for 52 weeks in the double-blind (DB) treatment period. Eligible participants were rolled over to an open-label extension (OLE) period to receive 150 mg GLPG2737 orally once daily for 52 weeks. Placebo During DB + GLPG2737 During OLE GLPG2737 Participants received placebo matched to GLPG2737 capsules orally once daily for 52 weeks in the DB treatment period. Eligible participants were rolled over to an OLE period to receive 150 mg GLPG2737 orally once daily for 52 weeks.
- Primary Outcome Measures
Name Time Method DB Period: Mean Percent Change From MRI Baseline in htTKV MRI Baseline up to Week 52 htTKV is used in participants with ADPKD disease to predict the onset of renal insufficiency. htTKV was calculated using TKV (in mL) obtained from MRI divided by height (in m). MRI Baseline: For MRI assessments, all non-missing values before the first study drug administration in the study +14 days (included) was considered as the primary baseline definition. Results were derived by mean of the individual slopes (i.e. using all MRI performed between baseline and Week 52).
DB Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs From first dose to Week 56 An AE is any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug, whether or not considered related to it. A serious adverse event (SAE) is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results a congenital anomaly/birth defect or other medically important event. A TEAE was defined as an AE observed after starting administration of the study drug until 30 days after last DB dose or 1 day before OLE dose, whichever occurred first.
- Secondary Outcome Measures
Name Time Method DB Period: Maximum Observed Plasma Concentration (Cmax) of GLPG2737 and Its Metabolite Predose (within 30 minutes prior to dosing), 1, 1.5, 2, 3, 4, 5, 6, 7 hours post dose through Week 52 Cmax is the maximum observed plasma concentration of the drug. The metabolite of GLPG2737 is M4.
DB Period: Mean Change From Baseline in eGFR Baseline up to Week 52 The eGFR is a test that measures level of kidney function and determines the stage of kidney disease. eGFR was based on CKD-EPI formula (2009) calculated from serum creatinine concentrations. Results were derived by mean of the individual slopes (i.e. using data between baseline and Week 52).
DB Period: Area Under the Plasma Concentration-Time Curve During a Dosing Interval (AUCtau) of GLPG2737 and Its Metabolite Predose (within 30 minutes prior to dosing), 1, 1.5, 2, 3, 4, 5, 6, 7 hours post dose through Week 52 AUC0-tau described the area under the curve limited to the end of a dosing interval. The metabolite of GLPG2737 is M4.
Trial Locations
- Locations (20)
DaVita Sp. z o.o. Stacja Dializ
🇵🇱Warsaw, Poland
Hospital Universitario Dr. Peset
🇪🇸Valencia, Spain
Nefrologia Clinica C.P.
🇪🇸Madrid, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Fakultni nemocnice Hradec Kralove
🇨🇿Hradec Králové, Czechia
Fondazione Salvatore Maugeri IRCCS
🇮🇹Pavia, Italy
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha, Czechia
Fundacion Puigvert
🇪🇸Barcelona, Spain
Radboud UMC
🇳🇱Nijmegen, Netherlands
IRCSS Ospedale San Raffaele
🇮🇹Milan, Italy
Amsterdam UMC
🇳🇱Amsterdam, Netherlands
UMCG
🇳🇱Groningen, Netherlands
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
Fakultni nemocnice u sv. Anny v Brne
🇨🇿Brno, Czechia
Cliniques Universitaires St. Luc (UCL)
🇧🇪Brussels, Belgium
Uniklinikum Dresden
🇩🇪Dresden, Germany
Uni Campania L. Vanvitelli
🇮🇹Napoli, Italy
Specjalistyczne Centrum Medyczne SCM Spółka z o.o.
🇵🇱Kraków, Poland
Szpital Kliniczny UM w Lodzi
🇵🇱Łódź, Poland
UZ Leuven
🇧🇪Leuven, Belgium