Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT05373264

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

Led by University Medical Center Groningen · Updated on 2026-02-25

300

Participants Needed

12

Research Sites

360 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with autosomal dominant polycystic kidney disease (ADPKD) using modified Ravine criteria
  • At least 18 years old
  • Estimated glomerular filtration rate (eGFR) greater than 25 mL/min/1.73m2
  • On stable treatment with the highest tolerated dose of a V2 receptor antagonist for at least 3 months
Not Eligible

You will not qualify if you...

  • Known intolerance to hydrochlorothiazide
  • Use of any diuretic medication
  • Complaints of orthostatic hypotension or blood pressure lower than 105/65 mmHg during screening
  • Uncontrolled high blood pressure (greater than 160/100 mmHg)
  • Low potassium levels (hypokalemia below 3.5 mmol/L)
  • History of active gout with two or more episodes in the last year and on preventive treatment
  • History of skin cancer including basal cell, squamous cell, or melanoma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Actively Recruiting

2

University Hospital Leuven

Leuven, Belgium

Actively Recruiting

3

Hospital La Cavale Blanche

Brest, France

Actively Recruiting

4

Necker-Enfants Malades Hospital

Paris, France

Actively Recruiting

5

Charité University Hospital

Berlin, Germany

Actively Recruiting

6

University Hospital Cologne

Cologne, Germany

Actively Recruiting

7

Med. Klinik und Poliklinik III, Universitätsklinikum Dresden.

Dresden, Germany

Actively Recruiting

8

Amsterdam University Medical Center

Amsterdam, Netherlands

Actively Recruiting

9

University Medical Center Groningen

Groningen, Netherlands

Actively Recruiting

10

Erasmus University Medical Center

Rotterdam, Netherlands

Actively Recruiting

11

Fundación Puigvert

Barcelona, Spain

Actively Recruiting

12

La Fundación Jiménez Díaz

Madrid, Spain

Actively Recruiting

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Research Team

D

Dr. E Meijer

CONTACT

T

T. Bais, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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