Everolimus and Long-term Clinical Outcomes in Kidney Transplant Recipients: A Registry-based 10-year Follow-up of Five Randomized Trials

Background Data regarding the long-term efficacy of everolimus-based immunosuppression for kidney transplantation are lacking. Existing randomised controlled trials are limited by short follow-up duration which limits capacity to assess impact on graft and patient survival. Methods We linked individual trial participants to the Australian and New Zealand Dialysis and Transplant Registry. Using a one-step meta-analysis approach, we investigated the ten-year risk of graft loss, mortality and graft function in 349 participants from five randomised-trials of everolimus-based immunosuppression. Results Two-hundred and forty-two patients randomised to everolimus and 107 control patients were followed for a median of 9-years (IQR 7.1, 9.8 years). There were no significant differences in the risk of all-cause graft loss [adjusted HR (95% confidence interval) 1.16 (0.69-1.94)], mortality [adjusted HR 1.51 (0.78-2.93)] and death-censored graft loss in everolimus versus control [adjusted HR 1.00 (0.50-2.01)). For patients in the early initiation (de novo or

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