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RECRUITING
NCT05373264
PHASE3

HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life

Sponsor: University Medical Center Groningen

View on ClinicalTrials.gov

Summary

Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive formation of renal cysts which ultimately lead to a loss of renal function. Tolvaptan (a V2R antagonist) is currently the only effective treatment for preserving renal function in ADPKD. However, side-effects such as polyuria limit its tolerability and thereby the therapeutic potential. This study will test whether co-administration with hydochlorothiazide can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in ADPKD. Approximately 300 patients will be enrolled.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2024-07-31

Completion Date

2031-07

Last Updated

2026-02-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Hydrochlorothiazide 25 mg

An oral capsule containing 25mg of hydrochlorothiazide

DRUG

Placebo

A matching oral capsule containing placebo

Locations (12)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

University Hospital Leuven

Leuven, Belgium

Hospital La Cavale Blanche

Brest, France

Necker-Enfants Malades Hospital

Paris, France

Charité University Hospital

Berlin, Germany

University Hospital Cologne

Cologne, Germany

Med. Klinik und Poliklinik III, Universitätsklinikum Dresden.

Dresden, Germany

Amsterdam University Medical Center

Amsterdam, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands

Fundación Puigvert

Barcelona, Spain

La Fundación Jiménez Díaz

Madrid, Spain