In Brief | Transplant Medicine
Transplant Medicine: Immunosuppression Optimisation in Older Kidney Transplant Recipients: Results from the OPTIMIZE Trial
[DD Month 2026]
Study Snapshot
| Design | Multicentre, open-label, randomised controlled trial (investigator-initiated, OPTIMIZE) |
| Population | 379 de novo kidney transplant recipients aged ≥65 years, stratified by donor age |
| Comparison | Low-dose tacrolimus + everolimus + prednisolone (TEP, n=187) vs standard-dose tacrolimus + mycophenolate mofetil + prednisolone (TMP, n=192) |
| Primary Outcome | Successful transplantation at 2 years (patient and graft survival plus a predefined eGFR threshold): 50% (TEP) vs 57% (TMP); difference 7% (95% CI −17 to 3); P=0.91 |
Summary
Older kidney transplant recipients face a distinct risk profile — lower rejection risk but greater susceptibility to infection, malignancy, and Calcineurin Inhibitor(CNI) related nephrotoxicity, prompting interest in CNI-sparing regimens.
The OPTIMIZE trial randomised 379 de novo recipients aged 65 years and older to either low-dose tacrolimus with everolimus and prednisolone, or standard-dose tacrolimus with mycophenolate mofetil and prednisolone.
Despite achieving protocol-defined trough concentrations for both tacrolimus and everolimus, the CNI-minimisation arm showed no advantage: successful transplantation at two years occurred in 50% versus 57% of the standard-therapy arm, with identical patient survival (89% vs 89%) and similar graft survival (83% vs 84%). No significant differences emerged in kidney function, biopsy-proven acute rejection, infection rates, or outcomes within either donor-age stratum.
For clinicians managing older transplant recipients, these findings do not support a routine switch away from standard tacrolimus-MMF-based regimens for the sake of CNI minimisation alone.
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