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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: ADPKD

In brief

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.

Key facts

Study ID

NCT05373264

Run by

University Medical Center Groningen

People needed

300

Starts

2024-07-31

Expected to finish

2031-07-01

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Cliniques Universitaires Saint-Luc — Brussels, Belgium (enrolling)
• University Hospital Leuven — Leuven, Belgium (enrolling)
• Hospital La Cavale Blanche — Brest, France (enrolling)
• Necker-Enfants Malades Hospital — Paris, France (enrolling)
• Charité University Hospital — Berlin, Germany (enrolling)
• University Hospital Cologne — Cologne, Germany (enrolling)
• Med. Klinik und Poliklinik III, Universitätsklinikum Dresden. — Dresden, Germany (enrolling)
• Amsterdam University Medical Center — Amsterdam, Netherlands (enrolling)
• University Medical Center Groningen — Groningen, Netherlands (enrolling)
• Erasmus University Medical Center — Rotterdam, Netherlands (enrolling)
• Fundación Puigvert — Barcelona, Spain (enrolling)
• La Fundación Jiménez Díaz — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.