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Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Completed to Active, Not Recruiting Completion date: May 13, 2026 to Jan 19, 2027 · Secondary endpoints revised (11)v10 Show 2 more changesShow less
    • Completion date: May 13, 2026 to Jan 19, 2027
    • Secondary endpoints revised (11)

    See this version in full on ClinicalTrials.gov ↗

  2. Trial completed Completion moved earlier from Dec 30, 2026 to May 13, 2026 · Primary completion date changed from estimate of May 7, 2026 to May 13, 2026v9 Show 2 more changesShow less
    • Completion moved earlier from Dec 30, 2026 to May 13, 2026
    • Primary completion date changed from estimate of May 7, 2026 to May 13, 2026
  3. Study sites: 297 to 308 Primary completion date: Dec 30, 2026 to May 7, 2026 · Secondary endpoints: 3 to 11 · Study description revised · 2 morev8 Show 5 more changesShow less
    • Primary completion date: Dec 30, 2026 to May 7, 2026
    • Secondary endpoints: 3 to 11
    • Study description revised
    • Eligibility criteria expanded, about 1 word
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 1 to 297v7
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 470 to confirmed 530 · Site details revisedv6 Show 2 more changesShow less
    • Enrollment target: estimated 470 to confirmed 530
    • Site details revised
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Start date: Mar 11, 2022 to Mar 15, 2022v4
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 2022 to Mar 11, 2022 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Mar 2022 to Mar 11, 2022
    • Site details revised
  4. Study description revisedv2 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy
Trial Details
NCT Number NCT05248646
Lead Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions Immunoglobulin A Nephropathy
Enrollment 530 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov