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Free Content Improved Renal Function After Early Conversion From a Calcineurin Inhibitor to Everolimus: a Randomized Trial in Kidney Transplantation

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In an open‐label, multicenter trial, de novo kidney transplant recipients at low to medium immunological risk were randomized at week 7 posttransplant to remain on CsA (n = 100, controls) or convert to everolimus (n = 102), both with enteric‐coated mycophenolate sodium and corticosteroids. The primary endpoint, change in measured GFR (mGFR) from week 7 to month 12, was significantly greater with everolimus than controls: 4.9 (11.8) mL/min versus 0.0 (12.9) mL/min (p = 0.012; analysis of covariance [ANCOVA]). Per protocol analysis demonstrated a more marked difference: an increase of 8.7 (11.2) mL/min with everolimus versus a decrease of 0.4 (12.0) mL/min in controls (p < 0.001; ANCOVA). There were no differences in graft or patient survival. The 12‐month incidence of biopsy‐proven acute rejection (BPAR) was 27.5% (n = 28) with everolimus and 11.0% (n = 11) in controls (p = 0.004). All but two episodes of BPAR in each group were mild. Adverse events occurred in 95.1% of everolimus patients and 90.0% controls (p = 0.19), with serious adverse events in 53.9% and 38.0%, respectively (p = 0.025). Discontinuation because of adverse events was more frequent with everolimus (25.5%) than controls (3.0%; p = 0.030). In conclusion, conversion from CsA to everolimus at week 7 after kidney transplantation was associated with a greater improvement in mGFR at month 12 versus CNI‐treated controls but discontinuations and BPAR were more frequent.
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Document Type: Research Article

Affiliations: 1: Transplant Institute, Sahlgrenska University Hospital, Göteborg, Sweden 2: Department of Nephrology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark 3: Department of Transplant Surgery, Uppsala University Hospital, Uppsala, Sweden 4: Department of Nephrology, Aarhus University Hospital, Skejby, Denmark 5: Department of Nephrology, Herlev Hospital, University of Copenhagen, Herlev, Denmark 6: Department of Nephrology, Odense University Hospital, Odense, Denmark 7: Department of Nephrology and Transplantation, Skåne University Hospital, Malmö, Sweden 8: Department of Transplant Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway 9: Capturo AS, Oslo, Norway 10: Medical Department, Novartis Norge AS, Oslo, Norway

Publication date: October 1, 2012

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