RCT Comparing Immunosuppressive Regimens in Elderly Renal Transplant Recipients

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

Outcome

Missed primary endpoint

paper successful transplantation at 2 years between the groups (TEP 94 [50%], TMP 110 [57%]; difference 7% [95% confidence interval, -17 to 3] P = 0.91). PMID 41201871 ↗

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

Indications