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Free Content Conversion From Cyclosporine to Everolimus at 4.5 Months Posttransplant: 3‐Year Results From the Randomized ZEUS Study

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The long‐term effect of conversion from calcineurin inhibitor (CNI) therapy to an mTOR inhibitor requires clarification. Following completion of the 12‐month, open‐label, multicenter ZEUS study, in which 300 kidney transplant recipients were randomized to continue cyclosporine (CsA) or convert to everolimus at 4.5 months posttransplant, outcomes were assessed at month 36 (n = 284; 94.7%). CNI therapy was reintroduced in 28.4% of everolimus patients by month 36. The primary efficacy endpoint, estimated glomerular filtration rate (Nankivell, ANCOVA) was significantly higher with everolimus versus the CsA group at month 24 (7.6 mL/min/1.73 m2, 95%CI 4.3, 11.0 mL/min/1.73 m2; p < 0.001) and month 36 (7.5 mL/min/1.73 m2, 95%CI 3.6, 11.4 mL/min/1.73 m2; p < 0.001). The incidence of biopsy‐proven acute rejection from randomization to month 36 was 13.0% in the everolimus arm and 4.8% in the CsA arm (p = 0.015). Patient and graft survival, as well as incidences of malignancy, severe infections and hospitalization, were similar between groups. Kidney transplant patients who are converted from CsA to everolimus at month 4.5 and who remain on everolimus thereafter may achieve a significant improvement in renal function that is maintained to 3 years. There was a significantly higher rate of rejection in the everolimus arm but this did not exert a deleterious effect by 3 years posttransplant.
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Document Type: Research Article

Affiliations: 1: Department of Nephrology, Charité Universitätsmedizin Berlin, Berlin, Germany 2: Department of General, Visceral and Transplantation Surgery, Hannover Medical School, Hannover, Germany 3: Department of Nephrology, University of Heidelberg, Heidelberg, Germany 4: Transplant Center Cologne, Cologne General Hospital, Cologne, Germany 5: Department of Nephrology and Hypertension, University of Bern, Inselspital, Bern, Switzerland 6: Division of Nephrology, University Hospital, Zürich, Switzerland 7: Department of Biometry, Novartis Pharma, Nuernberg, Germany 8: Clinical Research Transplantation and Infectious Diseases, Novartis Pharma, Nuernberg, Germany 9: Division of Nephrology and Immunology, University Hospital of the RWTH Aachen, Aachen, Germany 10: Department of General Surgery, University of Münster, Münster, Germany 11: Department of Medicine, Division of Nephrology, University of Erlangen, Erlangen, Germany 12: Division of Nephrology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany 13: Department of Nephrology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany

Publication date: June 1, 2012

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