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Renal Allograft Tolerance Through Mixed Chimerism - SMC/MGH

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Jan 2027 → Jan 2029
See other at-risk trials from Massachusetts General Hospital

Record History

  1. Primary completion pushed from Jan 2027 to Jan 2029 Completion pushed from Jun 2027 to Jun 2029 · Eligibility criteria expanded, about 24 words Show 2 more changesShow less
    • Completion pushed from Jun 2027 to Jun 2029
    • Eligibility criteria expanded, about 24 words
  2. Re-verified, no change to tracked fieldsv9
  3. Primary completion date: Jan 2025 to Jan 2027 Trial status: Recruiting to Active, Not Recruiting · Completion date: Jun 2025 to Jun 2027 · Site details revisedv8 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Jun 2025 to Jun 2027
    • Site details revised
  4. Eligibility criteria expanded, about 6 words Site contact updatedv7 Show 1 more changeShow less
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 6 to 20 Eligibility criteria shortened, about 22 wordsv6 Show 1 more changeShow less
    • Eligibility criteria shortened, about 22 words

    See this version in full on ClinicalTrials.gov ↗

Show 4 earlier versionsHide 4 earlier versions
  1. Eligibility criteria shortened, about 5 wordsv5 See this version in full on ClinicalTrials.gov ↗
  2. Re-verified, no change to tracked fieldsv4
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Sep 2021 to Sep 1, 2021v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2021 to Sep 1, 2021
  4. Start date: Dec 2020 to Sep 2021 Primary endpoints revised (3) · Interventions: Combined bone marrow and kidney transplant (Procedure), Rituximab, Fludarabine, Cyclophosphamide, Thymic irradiation and Thymoglobulin… to Combined bone marrow and kidney transplant (Procedure), Rituximab, Fludarabine, Cyclophosphamide, Thymic irradiation and Siplizumab (Drug) · Eligibility criteria expanded, about 60 wordsv2 Show 3 more changesShow less
    • Primary endpoints revised (3)
    • Interventions: Combined bone marrow and kidney transplant (Procedure), Rituximab, Fludarabine, Cyclophosphamide, Thymic irradiation and Thymoglobulin… to Combined bone marrow and kidney transplant (Procedure), Rituximab, Fludarabine, Cyclophosphamide, Thymic irradiation and Siplizumab (Drug)
    • Eligibility criteria expanded, about 60 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.
The goal is to investigate the safety of the conditioning regimen, and its ability to induce donor/recipient lymphohematopoietic chimerism without Chimerism Transition Syndrome (CTS), which may result in donor-specific unresponsiveness (tolerance) to the renal allograft in the absence of maintenance immunosuppression.
Trial Details
NCT Number NCT04540380
Lead Sponsor Massachusetts General Hospital
Conditions Renal Failure
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov