• Transplantation · Jul 2009

    Randomized Controlled Trial Multicenter Study Comparative Study

    Incidence of delayed graft function and wound healing complications after deceased-donor kidney transplantation is not affected by de novo everolimus.

    • Laetitia Albano, François Berthoux, Marie-Christine Moal, Lionel Rostaing, Christophe Legendre, Robert Genin, Olivier Toupance, Bruno Moulin, Pierre Merville, Jean-Philippe Rerolle, François Bayle, Pierre François Westeel, Denis Glotz, Niloufar Kossari, Nicole Lefrançois, Bernard Charpentier, Anne-Sandrine Blanc, Fabienne Di Giambattista, Jacques Dantal, and RAD A2420 Study Group.
    • Service de Néphrologie et Transplantation Rénale, Hôpital Pasteur, Nice, France.
    • Transplantation. 2009 Jul 15; 88 (1): 69-76.

    BackgroundConcerns about delayed graft function (DGF) and wound healing complications with sirolimus has led to suggestions that everolimus introduction could be delayed after transplantation.MethodsIn a prospective, multicenter, open-label study, deceased-donor kidney transplant recipients at protocol-specified risk of DGF (defined as > or =1 dialysis session during the first week posttransplant excluding day 1) were randomized to start everolimus therapy on day 1 posttransplant (immediate everolimus [IE]), or from week 5 (delayed everolimus [DE]) with mycophenolic acid until everolimus was initiated. All patients received anti-interleukin-2 receptor antibodies, cyclosporine A, and corticosteroids. A planned 3-month analysis from this 12-month study is presented here.ResultsOne hundred and thirty-nine patients were randomized (IE 65, DE 74). The primary composite endpoint: biopsy-proven acute rejection, graft loss, death, DGF, wound healing events, or lost to follow-up at month 3, occurred in 36 IE patients (55.4%) and 47 DE patients (63.5%, P=0.387). The incidence of DGF was similar between groups (IE 24.6%, DE 24.3%; n.s.). Wound healing events of any type occurred in 40.0% and 41.9% of IE and DE patients (n.s.); events relating to initial transplant surgery occurred in 36.9% IE patients and 37.8% DE patients (n.s.), most of which were fluid collections. Study drug was discontinued due to adverse events or graft loss in 13 IE (20.0%) and 17 DE patients (23.0%).ConclusionsFindings from this randomized, multicenter trial indicate that kidney function recovery, wound healing, efficacy, and tolerance are similar at 3 months posttransplant with immediate or DE in patients at protocol-specified risk of DGF.

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