HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life
University Medical Center Groningen
300 participants
Jul 31, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria7
- 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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Interventions
An oral capsule containing 25mg of hydrochlorothiazide
A matching oral capsule containing placebo
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT05373264