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Sponsor: University Medical Center Groningen
Conditions: ADPKD
Interventions: Hydrochlorothiazide 25 mg, Placebo
Countries: Belgium, France, Germany, Netherlands, Spain, Switzerland
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.
Sex: ALL
Age: 18 Years to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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)
- Antwerp, Belgium
- Brussels, Belgium
- Leuven, Belgium
- Bordeaux, France
- Brest, France
- Lyon, France
- Nancy, France
- Paris, France
- Berlin, Germany
- Cologne, Germany
- Dresden, Germany
- Amsterdam, Netherlands
- Groningen, Netherlands
- Rotterdam, Netherlands
- Alcázar de San Juan, Spain
- Barcelona, Spain
- Barcelona, Spain
- Madrid, Spain
- Bern, Switzerland
- Fribourg, Switzerland
- Geneva, Switzerland
- Zurich, Switzerland