HYDROchlorothiazide to PROTECT polycystic kidney disease patients and improve their quality of life (HYDRO-PROTECT
- Conditions
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)MedDRA version: 20.0Level: LLTClassification code: 10036046Term: Polycystic kidney autosomal dominant Class: 10010331Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- CTIS2022-500210-26-00
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 320
1) ADPKD diagnosis (modified Ravine criteria) 2 =18 years old 3) eGFR > 25 mL/min/1.73m2 (in Belgium eGFR > 35 mL/min/1.73m2) 4) On stable treatment with the highest tolerated dose of V2RA for a minimum of 3 months
1) Known intolerance to hydrochlorothiazide 2) Use of any diuretic 3) Changes in antihypertensive treatment in the last month 4) Orthostatic hypotension or blood pressure < 105/65 mmHg 5) Uncontrolled hypertension (blood pressure >160/100mmHg) 6) Hypokalemia (<3.5 mmol/L) 7) Diabetes mellitus type 1 or type 2 8) Primary renal disease other than ADPKD 9) History of active gout despite maintenance preventive treatment for gout (allopurinol, desuric, febuxostat and/or colchicine), defined as =2 episodes during the last year 10) History of skin cancer (basal cell, squamous cell and melanoma) 11) Anuria 12) Severe liver function impairment 13) Hypercalcemia 14) Salt losing nephropathy 15) Pregnancy 16) Breast feeding 17) Concurrent use of any medications listed under 8.1.2 18) Not able to give informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method