drugset / Trial / NCT05373264

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

NCT05373264

Phase 3 Recruiting 300 enrolled University Medical Center Groningen
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2024-07-31
Primary completion
2030-07
Completion
2031-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Hydrochlorothiazide Unknown 25 mg Oral