De Novo Everolimus-based Therapy for Renal Transplantation Using Rituximab Induction
Status:
Terminated
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
The investigators hypothesized that everolimus-based immunosuppressive therapy combined with
rituximab induction could provide comparable safety profiles for renal transplant patients,
as compared to standard immunosuppressive therapy using thymoglobulin induction, tacrolimus,
mycophenolate mofetil and steroids, in terms of acute rejection rate and renal function.
Rituximab was reported to reverse refractory acute kidney transplant rejection. Combined with
immunoadsorption with or without IVIG, rituximab could successfully prevent antibody-mediated
rejection in ABO-incompatible renal transplantation. This study is to assess whether a
CNI-free regimen including B-cell depleting antibody induction, everolimus and MMF results in
comparable long-term function without a negative impact on safety or efficacy of
immunosuppression. This study will be open-label and two-arm randomized (2:1).