作者
Julio Pascual, Stefan P Berger, Oliver Witzke, Helio Tedesco, Shamkant Mulgaonkar, Yasir Qazi, Steven Chadban, Federico Oppenheimer, Claudia Sommerer, Rainer Oberbauer, Yoshihiko Watarai, Christophe Legendre, Franco Citterio, Mitchell Henry, Titte R Srinivas, Wen-Lin Luo, AnaMaria Marti, Peter Bernhardt, Flavio Vincenti, TRANSFORM Investigators
发表日期
2018/7/1
期刊
Journal of the American Society of Nephrology
卷号
29
期号
7
页码范围
1979-1991
出版商
LWW
简介
Background Everolimus permits reduced calcineurin inhibitor (CNI) exposure, but the efficacy and safety outcomes of this treatment after kidney transplant require confirmation.
Methods In a multicenter noninferiority trial, we randomized 2037 de novo kidney transplant recipients to receive, in combination with induction therapy and corticosteroids, everolimus with reduced-exposure CNI (everolimus arm) or mycophenolic acid (MPA) with standard-exposure CNI (MPA arm). The primary end point was treated biopsy-proven acute rejection or eGFR< 50 ml/min per 1.73 m 2 at post-transplant month 12 using a 10% noninferiority margin.
Results In the intent-to-treat population (everolimus n= 1022, MPA n= 1015), the primary end point incidence was 48.2%(493) with everolimus and 45.1%(457) with MPA (difference 3.2%; 95% confidence interval,− 1.3% to 7.6%). Similar between-treatment differences in incidence were …
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J Pascual, SP Berger, O Witzke, H Tedesco… - Journal of the American Society of Nephrology, 2018