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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: University Medical Center Groningen • ClinicalTrials.gov ID: NCT05373264

Registry updated: 2026-08-25
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Description

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.

Interventions

  • Hydrochlorothiazide 25 mg (Drug)
    An oral capsule containing 25mg of hydrochlorothiazide
  • Placebo (Drug)
    A matching oral capsule containing placebo

Eligibility criteria

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)

Conditions

ADPKD

Locations

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

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record