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Statin Therapy in Patients With Early Stage ADPKD

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion date: Apr 30, 2024 to Sep 30, 2025v10
  2. Primary completion date changed from estimate of Mar 31, 2024 to Mar 25, 2024 Completion date: Mar 31, 2024 to Apr 30, 2024v9 Show 1 more changeShow less
    • Completion date: Mar 31, 2024 to Apr 30, 2024
  3. Primary and study completion dates: Jan 2023 to Mar 31, 2024 Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 200 to confirmed 150 · Site details revisedv8 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 200 to confirmed 150
    • Site details revised
  4. Primary and study completion dates: Dec 2021 to Jan 2023v7
  5. 3 versions Re-verified since Sep 12, 2018, no change to tracked fieldsv4-v6
Show 2 earlier versionsHide 2 earlier versions
  1. Secondary endpoints revised (5) Study description expanded, about 11 wordsv3 Show 1 more changeShow less
    • Study description expanded, about 11 words

    See this version in full on ClinicalTrials.gov ↗

  2. Secondary endpoints: details revised at 5 of 5 entries Eligibility criteria shortened, about 4 wordsv2 Show 1 more changeShow less
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study plans to learn if pravastatin is helpful in slowing down the progression of kidney disease in adults with autosomal dominant polycystic kidney disease (ADPKD). Pravastatin has been approved by the Food and Drug Administration (FDA) for adults for treatment of hyperlipidemia (high cholesterol levels). The investigators are using pravastatin in this study as an investigational drug for treatment of ADPKD.
Trial Details
NCT Number NCT03273413
Lead Sponsor University of Colorado, Denver
Conditions ADPKD, Autosomal Dominant Polycystic Kidney
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov