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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
Author(s) -
Qazi Y.,
Shaffer D.,
Kaplan B.,
Kim D. Y.,
Luan F. L.,
Peddi V. R.,
Shihab F.,
Tomlanovich S.,
Yilmaz S.,
McCague K.,
Patel D.,
Mulgaonkar S.
Publication year - 2017
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/ajt.14090
Subject(s) - medicine , tacrolimus , everolimus , urology , basiliximab , mycophenolic acid , immunosuppression , transplantation , anti thymocyte globulin , surgery
In this 12‐month, multicenter, randomized, open‐label, noninferiority study, de novo renal transplant recipients ( RTxR s) were randomized (1:1) to receive everolimus plus low‐dose tacrolimus ( EVR + LT ac) or mycophenolate mofetil plus standard‐dose Tac ( MMF + ST ac) with induction therapy (basiliximab or rabbit anti‐thymocyte globulin). Noninferiority of composite efficacy failure rate (treated biopsy‐proven acute rejection [ tBPAR ]/graft loss/death/loss to follow‐up) in EVR + LT ac versus MMF + ST ac was missed by 1.4%, considering the noninferiority 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 + LT ac versus MMF + ST ac groups, respectively. Mean estimated glomerular filtration rate was similar between EVR + LT ac and MMF + ST ac groups (63.1 [22.0] vs. 63.1 [19.5] mL /min/1.73 m 2 ) and safety was comparable. In conclusion, EVR + LT ac missed noninferiority versus MMF + ST ac based on the 10% noninferiority margin. Further studies evaluating optimal immunosuppression for improved efficacy will guide appropriate dosing and target levels of EVR and LT ac in RTxR s.