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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04578548
Recruitment Status : Active, not recruiting
First Posted : October 8, 2020
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autosomal Dominant Polycystic Kidney Disease Drug: Placebo Drug: GLPG2737 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 10, 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: DB Period: GLPG2737
GLPG2737 will be administered orally once daily with food for 52 weeks.
 Drug: GLPG2737
Capsules administered orally with food
Placebo Comparator: DB Period: Placebo
Matching placebo will be administered orally once daily with food for 52 weeks.
 Drug: Placebo
Matching placebo capsules administered orally with food
Experimental: OLE Period: GLPG2737
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.
 Drug: GLPG2737
Capsules administered orally with food


Outcome Measures
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Primary Outcome Measures :
  1. Mean Percent Change From Baseline of Height-Adjusted Total Kidney Volume (htTKV) [ Time Frame: From baseline until 52 weeks ]
  2. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From Day 1 until 56 weeks ]
  3. Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) [ Time Frame: From Day 1 until 56 weeks ]
  4. Percentage of Participants With TEAEs According to Severity [ Time Frame: From Day 1 until 56 weeks ]
  5. Percentage of Participants With TEAEs Leading to Treatment Discontinuation [ Time Frame: From Day 1 until 52 weeks ]

Secondary Outcome Measures :
  1. Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: From baseline until 52 weeks ]
  2. Area Under the Plasma Concentration-Time Curve During a Dosing Interval (AUCtau) of GLPG2737, estimated based on population pharmacokinetics (PK) modelling [ Time Frame: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 5-7, 8-9 hours postdose on Week 4 ]
  3. AUCtau of G1125498 (Major Active Metabolite of GLPG2737), estimated based on population PK modelling [ Time Frame: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 5-7, 8-9 hours postdose on Week 4 ]
  4. Maximum Observed Plasma Concentration (Cmax) of GLPG2737, estimated based on population PK modelling [ Time Frame: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 5-7, 8-9 hours postdose on Week 4 ]
  5. Cmax of G1125498 (Major Active Metabolite of GLPG2737), estimated based on population PK modelling [ Time Frame: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 5-7, 8-9 hours postdose on Week 4 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04578548


Locations
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Sponsors and Collaborators
Galapagos NV
Investigators
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Study Director: Ann Fieuw, MD, MSc Galapagos NV
More Information
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Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT04578548    
Other Study ID Numbers: GLPG2737-CL-203
2019-003521-21 ( EudraCT Number )
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Arthrogryposis
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Joint Diseases
Musculoskeletal Diseases
 Muscular Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities
Kidney Diseases, Cystic
Abnormalities, Multiple
Ciliopathies
Genetic Diseases, Inborn