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Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients

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

Record History

  1. Minor Trial status: Recruiting to Active, Not Recruitingv4 Show 4 more changesShow less
    • Enrollment target: estimated 20 to confirmed 9
    • Primary completion date changed from estimate of Jun 30, 2023 to May 23, 2023
    • Study completion date: Jul 15, 2023 to Sep 30, 2024
    • Site details revised
  2. Minor Primary completion date: Mar 31, 2023 to Jun 30, 2023
    • Study completion date: Jun 15, 2023 to Jul 15, 2023
    v3
  3. Minor Primary completion date: Dec 31, 2022 to Mar 31, 2023v2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 hypothesis of this proof-of-concept study is that EPO increases the frequency, stability and/or function of Tregs in liver transplant recipients. We also hypothesize that EPO will have a greater effect in everolimus vs. tacrolimus treated LTR, thus providing the rationale for a subsequent clinical trial to utilize EPO in combination with everolimus as a more successful pathway toward tolerance.
Trial Details
NCT Number NCT05325073
Lead Sponsor Northwestern University
Conditions
(from sponsor)
Liver Transplant Rejection
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov