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Clinical Trials in the Netherlands / NCT05373264
Recruiting Phase 3

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

NCT05373264 · tracked via the Priya Life Science Netherlands tracker
Sponsor
University Medical Center Groningen
Phase
Phase 3
Started
2024-07-31
Last updated
2026-08-25

Condition(s) studied

ADPKD

Investigational drug(s) / intervention(s)

Hydrochlorothiazide 25 mg →Placebo

Hydrochlorothiazide 25 mg: An oral capsule containing 25mg of hydrochlorothiazide

Placebo: A matching oral capsule containing placebo

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * ADPKD diagnosis (modified Ravine criteria) * ≥18 years old * eGFR \> 25 mL/min/1.73m2 * On stable treatment with the highest tolerated dose of V2RA for a minimum of 3 months Exclusion Criteria: * Known intolerance to hydrochlorothiazide * Use of any diuretic * Orthostatic hypotension complaints or blood pressure \<105/65mmHg during screening visit * Uncontrolled hypertension (blood pressure \>160/100mmHg) * Hypokalemia (\<3.5 mmol/L) * History of active gout on maintenance preventive treatment for gout (allopurinol, desuric and/or colchicine), defined as ≥2 episodes during the last year * History of skin cancer (basal cell, squamous cell and melanoma)

Primary outcome measure(s)

  • Changes in kidney function decline — 156 weeks
    The primary outcome is the change in kidney function decline (assessed as eGFR slope, in ml/min/1.73 m2 per year), calculated with linear mixed models, using all available creatinine values from week 12 until end of treatment between the tolvaptan/placebo and tolvaptan/HCT group.

Trial sites (25)

FacilityCityRegionStatus
Uniklinikum Graz Graz Austria Recruiting
Medizinische Universität Innsbruck Innsbruck Austria Recruiting
Universitair Ziekenhuis Antwerpen (UZA) Antwerp Belgium Recruiting
Cliniques Universitaires Saint-Luc Brussels Belgium Recruiting
University Hospital Leuven Leuven Belgium Recruiting
Hôpital Pellegrin (CHU Bordeaux) Bordeaux France Recruiting
Hospital La Cavale Blanche Brest France Recruiting
Centre Hôpital Universitaire de Lyon Lyon France Recruiting
Hôpitaux de Brabois (CHRU) Nancy France Recruiting
Necker-Enfants Malades Hospital Paris France Recruiting
Charité University Hospital Berlin Germany Recruiting
University Hospital Cologne Cologne Germany Recruiting
Med. Klinik und Poliklinik III, Universitätsklinikum Dresden. Dresden Germany Recruiting
Universitätsklinikum Leipzig Leipzig Germany Recruiting
Amsterdam University Medical Center Amsterdam Netherlands Recruiting
University Medical Center Groningen Groningen Netherlands Recruiting
Erasmus University Medical Center Rotterdam Netherlands Recruiting
Hospital Universitario Mancha Centro Alcázar de San Juan Spain Recruiting
Fundación Puigvert Barcelona Spain Recruiting
Hospital Universitario Vall D'Hebron Barcelona Spain Recruiting
La Fundación Jiménez Díaz Madrid Spain Recruiting
Universitätsspital Bern (Inselsspital) Bern Switzerland Recruiting
Hôpital Fribourgeois (HFR) Fribourg Switzerland Recruiting
Hôpitaux Universitaires de Genève (HUG) Geneva Switzerland Recruiting
Universitätsspital Zürich (USZ) Zurich Switzerland Recruiting

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Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET Starting soon
NAtural Course and Prognosis of PFIC and Effect of Biliary Diversion Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05373264 on ClinicalTrials.gov ↗ ← All trials in the Netherlands