Hydrochlorothiazide added to tolvaptan to protect kidneys and improve quality of life in ADPKD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an investigator-driven, randomized, placebo-controlled multicenter Phase 3 trial enrolling about 300 adults with ADPKD who are on a stable, highest tolerated dose of a V2 receptor antagonist (tolvaptan). Participants are randomized 1:1 to receive oral hydrochlorothiazide 25 mg once daily or matching placebo for 156 weeks. The primary outcome is the slope of kidney function decline measured by eGFR, with routine study visits every 12 weeks and one additional visit or phone call two weeks after starting treatment. The design aims to measure both efficacy on kidney function and effects on tolerability and quality of life compared with placebo.

Why it matters

Who can join: the full rules

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)

Where it's running

• 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

Study contacts

• Principal investigator: Prof. dr. R.T. Gansevoort — University Medical Center Groningen
• Study coordinator: Dr. E Meijer
• Email: esther.meijer@umcg.nl
• Phone: +31 50 3616161

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.