NCT05373264

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Aims: The main objectives of the current study are to prospectively test whether HCT co-treatment can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in PKD. Study design: Investigator driven randomized placebo-controlled multicenter trial Study population: 300 ADPKD patients of ≥18 years, with an eGFR of \> 25 mL/min/1.73m2, on stable treatment with the highest tolerated dose of V2RA Intervention: Oral HCT 25 mg once daily or matching placebo for a total of 156 weeks. The randomization ratio will be 1:1. Study visit schedule: study measurements will be performed during 12-weekly visits (which is routine care for V2RA treated patients), except for one additional study visit (or telephone call) 2 weeks after the start of treatment Primary study outcome: Slope of kidney function decline (measured by eGFR)

Conditions

• ADPKD

Interventions

Type	Name	Description
DRUG	Hydrochlorothiazide 25 mg	An oral capsule containing 25mg of hydrochlorothiazide
DRUG	Placebo	A matching oral capsule containing placebo

Timeline

• Start date: 2024-07-31
• Primary completion: 2030-07-01
• Completion: 2031-07-01
• First posted: 2022-05-13
• Last updated: 2026-02-25

Locations

12 sites across 5 countries: Belgium, France, Germany, Netherlands, Spain