A randomized exploratory trial of steroid avoidance in renal transplant patients treated with everolimus and low-dose cyclosporine

Giuseppe Montagnino, Silvio Sandrini, Beniamino Iorio, Francesco Paolo Schena, Mario Carmellini, Paolo Rigotti, Maria Cossu, Paolo Altieri, Maurizio Salvadori, Sergio Stefoni, Giuseppe Corbetta, Claudio Ponticelli

Research output: Contribution to journalArticlepeer-review


Background. Everolimus and cyclosporine exhibit synergistic immunosuppressive activity when given in combination. In this randomized trial, we explored whether the use of everolimus associated with low-dose cyclosporine could allow an early avoidance of steroids in de novo renal transplant recipients. Methods. In this exploratory multicenter trial, 65 out of 133 patients treated with basiliximab (days 0 and 4), everolimus 3 mg/day and cyclosporine were randomized to stop steroids on the seventh post-transplant day (group A), whereas the remaining 68 continued low-dose steroid treatment (group B). Results. During the follow-up, 30 patients of group A (46%) resumed steroids. According to the intention-to-treat analysis, the 3-year graft survival rate was 95% in group A and 87% in group B (P = ns). There were more biopsy-proven rejections in group A, the difference being of borderline significance (32% vs 18%; P = 0.059). After 3 years, mean creatinine clearance was 52.3 ± 17.1 ml/min in group A and 52.2 ± 21.5 ml/min in group B. It was similar in the group A patients who experienced rejection (49.8 ± 14.7 ml/min) and those who did not (53.6 ± 18.3 ml/min; P = 0.319). Mean serum cholesterol and triglyceride levels were, respectively, less than 250 mg/dl and less than 200 mg/dl in both groups, without any significant difference. Vascular thrombosis (0 vs 11.7%; P = 0.0043) was more frequent in group B. Conclusions. Treatment based on everolimus and low-dose cyclosporine allowed excellent renal graft survival and stable graft function at 3 years. An early discontinuation of steroids increased the risk of acute rejection, but was associated with a better graft survival in the long-term. However, it was well tolerated only by 54% of patients.

Original languageEnglish
Pages (from-to)707-714
Number of pages8
JournalNephrology Dialysis Transplantation
Issue number2
Publication statusPublished - Feb 2008


  • Basiliximab everolimus and cyclosporine immunosuppression: cyclosporine
  • Early steroid withdrawal
  • Everolimus
  • Kidney transplant
  • Steroid free

ASJC Scopus subject areas

  • Nephrology
  • Transplantation


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