RecruitingPhase 3NCT05373264

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


Sponsor

University Medical Center Groningen

Enrollment

300 participants

Start Date

Jul 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Hydrochlorothiazide 25 mg and a drug called Placebo for people with adpkd. The study is currently recruiting participants at 12 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHydrochlorothiazide 25 mg

An oral capsule containing 25mg of hydrochlorothiazide

DRUGPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT05373264


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