Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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