August 5, 2011

The ORION Study: Comparison of Two Sirolimus-Based Regimens versus Tacrolimus and Mycophenolate Mofetil in Renal Allograft Recipients

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This randomized controlled trial in de novo renal transplant recipients compared a standard immunosuppressive protocol of daclizumab induction, tacrolimus, mycophenolate mofetil (MMF) and steroids, to either: sirolimus and tacrolimus, with tacrolimus discontinued by four months post-transplant, or sirolimus and MMF. The sirolimus and MMF group was stopped early due to a high incidence of acute rejection. At two years, there was no difference in renal function, acute rejection, graft or patient survival between the tacrolimus elimination and standard arms. There were no clear benefits with a calcineurin-inhibitor free regimen in this study.

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