Efficacy and Safety of Everolimus Plus Low-dose Tacrolimus Versus Mycophenolate Mofetil Plus Standard-dose Tacrolimus in De Novo Renal Transplant Recipients: 12-month Data

AJT - Early Efficacy and Safety of Everolimus Plus Low-dose Tacrolimus Versus Mycophenolate Mofetil Plus Standard-dose Tacrolimus in De Novo Renal Transplant Recipients: 12-month Data

Abstract

In this 12-month, multicenter, randomized, open-label, non-inferiority study, de novo renal transplant recipients (RTxRs) were randomized (1:1) to receive everolimus plus low-dose tacrolimus (EVR+LTac) or mycophenolate mofetil plus standard-dose Tac (MMF+STac) with induction therapy (basiliximab or rabbit anti-thymocyte globulin). Non-inferiority of composite efficacy failure rate (tBPAR/graft loss/death/loss to follow-up) in EVR+LTac versus MMF+STac, was missed by 1.4% considering the non-inferiority margin of 10% (24.6% vs 20.4%; 4.2%

[-3.0, 11.4]). Incidence of tBPAR (19.1% vs 11.2%; P<0.05) was significantly higher, while graft loss (1.3% vs 3.9%; P<0.05) and composite of graft loss/death/lost to follow-up (6.1% vs 10.5%, P = 0.05) were significantly lower in EVR+LTac versus MMF+STac groups, respectively. Mean eGFR was similar between EVR+LTac and MMF+STac groups (63.1 [22.0] vs 63.1 [19.5] mL/min/1.73 m²) and safety was comparable. In conclusion, EVR+LTac missed non-inferiority versus MMF+STac based on the 10% non-inferiority margin. Further studies evaluating optimal immunosuppression for improved efficacy will guide appropriate dosing and target-levels of EVR and LTac in RTxRs.

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http://onlinelibrary.wiley.com/resolve/doi?DOI=10.1111%2Fajt.14090

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