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RCT Comparing Immunosuppressive Regimens in Elderly Renal Transplant Recipients

Study acronym: OPTIMIZE
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 10, 2023 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Site details revised at 7 of 7 sitesv5 Show 1 more changeShow less
    • Site details revised at 7 of 7 sites
  2. Secondary endpoints: 19 to 20v4 See this version in full on ClinicalTrials.gov ↗
  3. Primary endpoint revised Eligibility criteria shortened, about 60 words · Secondary endpoints: 12 to 19 · Site details revised at 6 of 7 sitesv3 Show 3 more changesShow less
    • Eligibility criteria shortened, about 60 words
    • Secondary endpoints: 12 to 19
    • Site details revised at 6 of 7 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 2019 to Jul 29, 2019 · Study sites: 0 to 7 · Secondary endpoints revised (12)v2 Show 3 more changesShow less
    • Start date changed from estimate of Mar 2019 to Jul 29, 2019
    • Study sites: 0 to 7
    • Secondary endpoints revised (12)

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Open label, randomized, multicenter, intervention trial comparing standard immunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen in combination with everolimus. The primary objective is to test the hypothesis that an age-adapted immunosuppressive regimen targeted at reduced immunosuppression with low calcineurin inhibitor (tacrolimus) exposure in combination with everolimus will result in improved outcome in elderly recipients of A: Kidneys from older deceased donors (\>64 years) and B: Kidneys from living donors (all ages) and younger deceased donors (\<65 years).
Trial Details
NCT Number NCT03797196
Lead Sponsor University Medical Center Groningen
Collaborators: Radboud University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Amsterdam UMC, location VUmc, UMC Utrecht, Leiden University Medical Center, Erasmus Medical Center, Universitaire Ziekenhuizen KU Leuven
Conditions Renal Transplant Recipients, Elderly Patients, Immunosuppression
Enrollment 374 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov