Details

Autor(en) / Beteiligte

• Albano, Laetitia
• Berthoux, François
• Moal, Marie-Christine
• Rostaing, Lionel
• Legendre, Christophe
• Genin, Robert
• Toupance, Olivier
• Moulin, Bruno
• Merville, Pierre
• Rerolle, Jean-Philippe
• Bayle, François
• Westeel, Pierre François
• Glotz, Denis
• Kossari, Niloufar
• Lefrançois, Nicole
• Charpentier, Bernard
• Blanc, Anne-Sandrine
• Di Giambattista, Fabienne
• Dantal, Jacques

Titel

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

Ist Teil von

• Transplantation, 2009-07, Vol.88 (1), p.69-76

Ort / Verlag

United States

Erscheinungsjahr

2009

Quelle

MEDLINE

Beschreibungen/Notizen

• Concerns about delayed graft function (DGF) and wound healing complications with sirolimus has led to suggestions that everolimus introduction could be delayed after transplantation. In 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. One 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%). Findings 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.