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A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints revised (4) Study description revisedv18 Show 1 more changeShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria expanded, about 89 words Secondary endpoints revised (4) · Study description revised · Study title expanded, about 2 wordsv17 Show 3 more changesShow less
    • Secondary endpoints revised (4)
    • Study description revised
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 1 of 23 sitesv16
  4. Study Status, Referencesv15
  5. Primary completion date: Feb 23, 2028 to Jul 31, 2028 Completion date: Feb 23, 2028 to Aug 14, 2028 · Site details revised at 1 of 23 sitesv14 Show 2 more changesShow less
    • Completion date: Feb 23, 2028 to Aug 14, 2028
    • Site details revised at 1 of 23 sites
Show 12 earlier versionsHide 12 earlier versions
  1. Site details revised at 1 of 23 sitesv13
  2. Start date: Jul 15, 2022 to Jan 23, 2023 Study sites revised (23) · Study title shortened, about 2 wordsv12 Show 2 more changesShow less
    • Study sites revised (23)
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment target: 10 to 20 Study sites: 28 to 23v11 Show 1 more changeShow less
    • Study sites: 28 to 23
  4. Study sites revised (28)v10 See this version in full on ClinicalTrials.gov ↗
  5. Primary and study completion dates: Apr 27, 2026 to Feb 23, 2028 Study sites: 19 to 28v9 Show 1 more changeShow less
    • Study sites: 19 to 28
  6. Site details revised at 1 of 19 sitesv8
  7. Re-verified, no change to tracked fieldsv7
  8. Enrollment target: 20 to 10 Eligibility criteria shortened, about 29 words · Site details revised at 2 of 19 sitesv6 Show 2 more changesShow less
    • Eligibility criteria shortened, about 29 words
    • Site details revised at 2 of 19 sites

    See this version in full on ClinicalTrials.gov ↗

  9. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 31, 2022 to Jul 15, 2022 · Site details revised at 19 of 19 sitesv5 Show 2 more changesShow less
    • Start date changed from estimate of Aug 31, 2022 to Jul 15, 2022
    • Site details revised at 19 of 19 sites
  10. Start date: Aug 12, 2022 to Aug 31, 2022v4
  11. Primary and study completion dates: Jan 26, 2026 to Apr 27, 2026 Start date: Jul 22, 2022 to Aug 12, 2022v3 Show 1 more changeShow less
    • Start date: Jul 22, 2022 to Aug 12, 2022
  12. Primary completion date: Mar 31, 2025 to Jan 26, 2026 Start date: Apr 1, 2021 to Jul 22, 2022 · Study sites: 0 to 19 · Completion date: Jun 1, 2025 to Jan 26, 2026 · 3 morev2 Show 6 more changesShow less
    • Start date: Apr 1, 2021 to Jul 22, 2022
    • Study sites: 0 to 19
    • Completion date: Jun 1, 2025 to Jan 26, 2026
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: 3 to 4
    • Study description expanded, about 18 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.
To evaluate the pharmacodynamics and safety of tolvaptan in pediatric subjects with ARPKD
Trial Details
NCT Number NCT04782258
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions Autosomal Recessive Polycystic Kidney (ARPKD)
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov