Five‐year outcomes in kidney transplant patients randomized to everolimus with cyclosporine withdrawal or low‐exposure cyclosporine versus standard therapy

HERAKLES was a 1‐year randomized, multicenter trial. Patients were randomized at 3 months after kidney transplantation to remain on cyclosporine‐based therapy, switch to everolimus without a calcineurin inhibitor (CNI), or switch to everolimus with low‐exposure cyclosporine. Overall, 417 of 497 (83.9%) patients from the core study entered a 4‐year extension study. The randomized regimen was continued to year 5 in 75.9%, 41.9% and 24.6% of patients in the standard‐CNI, CNI‐free and low‐CNI groups, respectively. Adjusted estimated GFR at year 5 was significantly higher in the CNI‐free group versus standard CNI (difference 7.2 mL/min/1.73 m2, P