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Summary  Kidney transplant recipients receiving calcineurin inhibitor‐based immunosuppression incur increased long‐term risks of cancer and kidney fibrosis. Switch to mammalian target of rapamycin ( mTOR ) inhibitors may reduce these risks. Steroid or  C yclosporin  R emoval  A fter  T ransplant using  E verolimus ( SOCRATES ), a 36‐month, prospective, multinational, open‐label, randomized controlled trial for  de novo  kidney transplant recipients, assessed whether everolimus switch could enable elimination of mycophenolate plus either steroids or  CNI  without compromising efficacy. Patients received cyclosporin, mycophenolate and steroids for the first 14 days then everolimus with mycophenolate and  CNI withdrawal ( CNI ‐ WD ); everolimus with mycophenolate and steroid withdrawal (steroid‐ WD ); or cyclosporin, mycophenolate and steroids (control). 126 patients were randomized. The steroid  WD  arm was terminated prematurely because of excess discontinuations. Mean  eGFR  at month 12 for  CNI ‐ WD  versus control was 65.1 ml/min/1.73 m 2  vs. 67.1 ml/min/1.73 m 2  by ITT, which met predefined noninferiority criteria ( P  = 0.026). The  CNI ‐ WD  group experienced a higher rate of  BPAR (31% vs. control 13%,  P  = 0.048) and showed a trend towards higher composite treatment failure ( BPAR , graft loss, death, loss to follow‐up). The 12 month results from  SOCRATES  show noninferiority in  eGFR , but a significant excess of acute rejection when everolimus was commenced at week 2 to enable a progressive withdrawal of mycophenolate and cyclosporin in kidney transplant recipients.

A randomized, controlled trial of everolimus‐based dual immunosuppression versus standard of care in de novo kidney transplant recipients