drugset / Trial / NCT03797196
RCT Comparing Immunosuppressive Regimens in Elderly Renal Transplant Recipients
Phase 4
Active not recruiting
374 enrolled
University Medical Center Groningen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · collabAmsterdam UMC, location VUmc · collabErasmus Medical Center · collabLeiden University Medical Center · collabRadboud University Medical Center · collabUMC Utrecht · collabUniversitaire Ziekenhuizen KU Leuven · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2019-07-29
- Primary completion
- 2025-06
- Completion
- 2026-12
Publications
- Sanders JF, de Boer SE, Jonker J, Bemelman FJ, Betjes MGH, de Vries APJ, Hilbrands L, Hilhorst M, Kuypers DRJ, Vart P, van Zuilen AD, Hesselink DA, Berger SP. Immunosuppression in Older Kidney Transplant Recipients: A Randomized Controlled Trial. J Am Soc Nephrol. 2026 Apr 1;37(4):814-824. doi: 10.1681/ASN.0000000924. Epub 2025 Nov 7.
- Oliveras L, Lopez-Vargas P, Melilli E, Codina S, Royuela A, Coloma Lopez A, Fava A, Manonelles A, Couceiro C, Lloberas N, Cruzado JM, Montero N. Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function. Cochrane Database Syst Rev. 2025 Apr 8;4(4):CD014855. doi: 10.1002/14651858.CD014855.pub2.
- de Boer SE, Sanders JSF, Bemelman FJ, Betjes MGH, Burgerhof JGM, Hilbrands L, Kuypers D, van Munster BC, Nurmohamed SA, de Vries APJ, van Zuilen AD, Hesselink DA, Berger SP. Rationale and design of the OPTIMIZE trial: OPen label multicenter randomized trial comparing standard IMmunosuppression with tacrolimus and mycophenolate mofetil with a low exposure tacrolimus regimen In combination with everolimus in de novo renal transplantation in Elderly patients. BMC Nephrol. 2021 Jun 2;22(1):208. doi: 10.1186/s12882-021-02409-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | — | — |
| Comparator | Mycophenolate Mofetil | Small molecule | — | — |
| Subject | Tacrolimus | Small molecule | — | — |