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

Sponsor
University Medical Center Groningen
Study ID
NCT05373264
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Hydrochlorothiazide 25 mg — DRUG
    An oral capsule containing 25mg of hydrochlorothiazide
  • Placebo — DRUG
    A matching oral capsule containing placebo

Study Details

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.

Key Dates

Start date
Jul 31, 2024
Status verified
Feb 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2031

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Hydrochlorothiazide
    Oral hydrochlorothiazide 25mg, once daily, for a total of 156 weeks
  • Placebo Comparator: Placebo
    Matching oral placebo, once daily, for a total of 156 weeks. The placebo is inert.

Primary Outcome Measure

Changes in kidney function decline [ Time Frame: 156 weeks ]

Central Contacts

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