Clinical Trial

RCT Comparing Immunosuppressive Regimens in Elderly Renal Transplant Recipients

Study acronym: OPTIMIZE
Active, Not Recruiting Phase 4
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.
Summary
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).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2019-01-04; most recent amendment 2023-05-09.
Status change: Recruiting → Active, Not Recruiting 2023-05-09
Status change: Not Yet Recruiting → Recruiting 2020-01-07
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 2019-07-29
Primary Completion 2025-06 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2023-05-10