Early conversion from calcineurin inhibitor- to everolimus-based therapy following kidney transplantation: Results of the randomized ELEVATE trial

Johan W de Fijter, Hallvard Holdaas, Ole Øyen, Jan Stephan Sanders, Sankaran Sundar, Frederike J Bemelman, Claudia Sommerer, Julio Pascual, Yingyos Avihingsanon, Cholatip Pongskul, Frederic Oppenheimer, Lorenzo Toselli, Graeme Russ, Zailong Wang, Patricia Lopez, Jossy Kochuparampil, Josep M Cruzado, Markus van der Giet, ELEVATE Study Group

OnderzoeksoutputAcademicpeer review

36 Citaten (Scopus)

Samenvatting

In a 24-month, multicenter, open-label, randomized trial, 715 de novo kidney transplant recipients were randomized at 10-14 weeks to convert to everolimus (n=359) or remain on standard calcineurin inhibitor (CNI) therapy (n=356; 231 tacrolimus; 125 cyclosporine), all with mycophenolic acid and steroids. The primary endpoint, change in estimated GFR from randomization to month 12, was similar for everolimus versus CNI: mean (SE) 0.3(1.5)mL/min/1.73(2) versus -1.5(1.5)mL/min/1.73(2) (p=0.116). At month 24, mean (SD) estimated GFR was 62.5(22.4)mL/min/1.73m(2) with everolimus and 57.4 (19.9) mL/min/1.73m(2) with CNI (p=0.005), and 59.7(20.5)mL/min/1.73m(2) and 53.0(18.0)mL/min/1.73m(2) , respectively, for the tacrolimus- and cyclosporine-treated CNI subgroups. BPAR at month 12 was more frequent under everolimus versus CNI overall (9.7% versus 4.8%, p=0.014) and versus tacrolimus-treated patients (2.6%, p<0.001) but similar to cyclosporine-treated patients (8.8%, p=0.755). Reporting on de novo donor specific antibodies (DSA) was limited but suggested more frequent anti-HLA Class I DSA under everolimus. Change in left ventricular mass index was similar. Discontinuation due to adverse events was more frequent with everolimus (23.6%) versus CNI (8.4%). In conclusion, conversion to everolimus at 10-14 weeks post-transplant was associated with similar renal function to standard therapy overall. Rates of BPAR were low in all groups, but lower with tacrolimus than everolimus. This article is protected by copyright. All rights reserved.

Originele taal-2English
Pagina's (van-tot)1853-1867
Aantal pagina's15
TijdschriftAmerican Journal of Transplantation
Volume17
Nummer van het tijdschrift7
Vroegere onlinedatum14-feb-2017
DOI's
StatusPublished - jul-2017

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