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

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Brief Title

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

Official Title

An Exploratory, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Orally Administered GLPG2737 for 52 Weeks, Followed by an Open-label Extension Period of 52 Weeks in Subjects With Autosomal Dominant Polycystic Kidney Disease

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 subjects
      with rapidly progressing ADPKD.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Mean Percent Change From Baseline of Height-Adjusted Total Kidney Volume (htTKV)

Secondary Outcome

 Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)

Condition

Autosomal Dominant Polycystic Kidney Disease

Intervention

Placebo

Study Arms / Comparison Groups

 DB Period: GLPG2737
Description:  GLPG2737 will be administered orally once daily with food for 52 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

66

Start Date

November 10, 2020

Completion Date

February 2024

Primary Completion Date

January 2023

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.
      

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Ann Fieuw, MD, MSc, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT04578548

Organization ID

GLPG2737-CL-203

Secondary IDs

2019-003521-21

Responsible Party

Sponsor

Study Sponsor

Galapagos NV


Study Sponsor

Ann Fieuw, MD, MSc, Study Director, Galapagos NV


Verification Date

November 2021