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Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans With Kidney Transplant

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 14, 2025 (before its estimated July 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Withdrawn to Active, Not Recruiting Primary completion date: Oct 31, 2020 to Jul 31, 2025 · Enrollment target: 0 to 46 · Completion date: Oct 31, 2022 to Oct 31, 2025v2 Show 3 more changesShow less
    • Primary completion date: Oct 31, 2020 to Jul 31, 2025
    • Enrollment target: 0 to 46
    • Completion date: Oct 31, 2022 to Oct 31, 2025
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In spite of conventional immunosuppression with lymphocyte-depleting induction followed by tacrolimus- and mycophenolate-based regimens, African American (AA) renal transplant recipients experience higher rates of acute rejection (AR), donor specific antibodies (DSA), and graft failure. Envarsus Extended-Release (XR)® (ENV) is a novel extended-release formulation of tacrolimus with a favorable pharmacokinetic profile, even in the setting of CYP3A5\*1 allele (rapid metabolizers). The investigator will evaluate the safety and efficacy of early dose escalation with ENV in AA recipients. The study hypothesis is that higher tacrolimus target concentrations may be achieved without typical dose-limiting toxicities, and this may ultimately result in lower incidence of early AR, DSA, and graft loss.
Trial Details
NCT Number NCT04665310
Lead Sponsor The Methodist Hospital Research Institute
Collaborators: Veloxis Pharmaceuticals
Conditions Kidney Disease, End-Stage, Donor Specific Antibodies, Acute Rejection of Renal Transplant
Enrollment 46 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov