Journal Article

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 and Claudio Ponticelli

in Nephrology Dialysis Transplantation

Published on behalf of European Renal Association - European Dialysis and Transplant Assoc

Volume 23, issue 2, pages 707-714
Published in print February 2008 | ISSN: 0931-0509
Published online September 2007 | e-ISSN: 1460-2385 | DOI: http://dx.doi.org/10.1093/ndt/gfm621
A randomized exploratory trial of steroid avoidance in renal transplant patients treated with everolimus and low-dose cyclosporine

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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.

Keywords: basiliximab everolimus and cyclosporine immunosuppression: cyclosporine; early steroid withdrawal; everolimus; kidney transplant; steroid free

Journal Article.  4594 words.  Illustrated.

Subjects: Nephrology

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