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

RecruitingPhase 3Ages 18 Years - 80 YearsAllUniversity Medical Center Groningen
NCT05373264 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • Hydrochlorothiazide 25 mg
  • Placebo
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Where

25 sites
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

…and 17 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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