Hydrochlorothiazide to Protect Polycystic Kidney Disease Patients and Improve Their Quality of Life

What this Trial Is About

The trial focuses on autosomal dominant polycystic kidney disease (ADPKD), which causes progressive kidney cysts leading to kidney function loss. Researchers are studying whether adding hydrochlorothiazide to standard treatment with a V2 receptor antagonist (V2RA), currently the only effective therapy, can slow kidney function decline and improve quality of life by reducing side effects like excessive urination. This phase 3, randomized, placebo-controlled study plans to enroll about 300 patients aged 18 to 80 years with ADPKD and adequate kidney function. Participants will receive either oral hydrochlorothiazide 25 mg once daily or a matching placebo for 156 weeks while continuing their stable highest tolerated dose of V2RA. The study is double-blinded and includes regular visits every 12 weeks, plus an additional check 2 weeks after starting the study treatment. The trial aims to compare kidney function decline between the two groups and assess tolerability and quality of life improvements. During the study, participants will have kidney function measured by estimated glomerular filtration rate (eGFR) over 156 weeks, with additional assessments at 168 weeks after treatment ends. Quality of life will be evaluated by several questionnaires including TIPS, ADPKD-UIS, SF-12, and EQ-5D. Safety monitoring includes blood pressure checks, serum electrolyte levels, and recording adverse events. Participants will be followed closely throughout the study period to track kidney health and treatment effects.

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