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

Study acronym: HYDRO-PROTECT
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 22 → 25 locationsv7
  2. Trial sites expanded: 12 → 22 locationsv6
  3. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jul 2028 to Jul 2030 · Start date changed from estimate of Mar 2024 to Jul 31, 2024 · Study sites: 13 to 12 · 1 morev5 Show 4 more changesShow less
    • Primary completion date: Jul 2028 to Jul 2030
    • Start date changed from estimate of Mar 2024 to Jul 31, 2024
    • Study sites: 13 to 12
    • Completion date: Jul 2029 to Jul 2031
  4. Start date: Jul 2023 to Mar 2024v4
  5. Primary completion date: Feb 2027 to Jul 2028 Start date: Feb 2023 to Jul 2023 · Completion date: Dec 2028 to Jul 2029v3 Show 2 more changesShow less
    • Start date: Feb 2023 to Jul 2023
    • Completion date: Dec 2028 to Jul 2029
  6. Study sites revised (13)v2 See this version in full on ClinicalTrials.gov ↗
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05373264
Lead Sponsor University Medical Center Groningen
Conditions ADPKD
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov