A randomized trial of everolimus and low-dose cyclosporine in renal transplantation: With or without steroids?

C. Ponticelli, M. Carmellini, G. Tisone, S. Sandrini, G. Segoloni, P. Rigotti, G. Colussi, S. Stefoni

Research output: Contribution to journalArticlepeer-review


This multicenter, randomized, prospective, controlled trial (EVIDENCE study) aimed to determine short-term effects of early steroid withdrawal in renal transplant patients initially treated with everolimus, low-dose cyclosporine (CsA), and steroids. Patients were randomized to standard triple therapy with CsA, everolimus twice daily and steroids (group A), steroid-free immunosuppression (group B), or triple therapy once daily (group C). However, since patient enrollment was slower than expected, group C randomization was prematurely discontinued. The primary end point was treatment failure rate (composite end point of death, graft loss, biopsy-proven acute rejection, and loss to follow-up) between randomization and month 12. Patients evaluable for the primary end point included 139 randomized patients. According to intention-to-treat analysis, 2.8% of patients in group A and 14.7% in group B experienced treatment failure (95% upper confidence limit 19.7%). As this was higher than the predefined noninferiority limit of 10%, noninferiority could not be proved. No conclusive statements can be made on noninferiority of the steroid withdrawal regimen vs the standard regimen in these patients. Additional studies with longer follow-up are required to determine the efficacy of steroidfree immunosuppression in renal transplant recipients receiving everolimus.

Original languageEnglish
Pages (from-to)3375-3382
Number of pages8
JournalTransplantation Proceedings
Issue number10
Publication statusPublished - 2014

ASJC Scopus subject areas

  • Surgery
  • Transplantation
  • Medicine(all)


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