title: Incidence of delayed graft function and wound healing complications after deceased-donor kidney transplantation is not affected by de novo everolimus.
abstract: BACKGROUND
  Concerns about delayed graft function (DGF) and wound healing complications with sirolimus has led to suggestions that everolimus introduction could be delayed after transplantation.
  
  
  METHODS
  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.
  
  
  RESULTS
  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%).
  
  
  CONCLUSIONS
  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.
authors: Service de Néphrologie et Transplantation Rénale, Hôpital Pasteur, Nice, France.
authors: Laetitia
authors: L
authors: Albano
authors: François
authors: F
authors: Berthoux
authors: Marie-Christine
authors: MC
authors: Moal
authors: Lionel
authors: L
authors: Rostaing
authors: Christophe
authors: C
authors: Legendre
authors: Robert
authors: R
authors: Genin
authors: Olivier
authors: O
authors: Toupance
authors: Bruno
authors: B
authors: Moulin
authors: Pierre
authors: P
authors: Merville
authors: Jean-Philippe
authors: JP
authors: Rerolle
authors: François
authors: F
authors: Bayle
authors: Pierre François
authors: PF
authors: Westeel
authors: Denis
authors: D
authors: Glotz
authors: Niloufar
authors: N
authors: Kossari
authors: Nicole
authors: N
authors: Lefrançois
authors: Bernard
authors: B
authors: Charpentier
authors: Anne-Sandrine
authors: AS
authors: Blanc
authors: Fabienne
authors: F
authors: Di Giambattista
authors: Jacques
authors: J
authors: Dantal
mesh_terms: D000368:Aged; D051799:Delayed Graft Function / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D000068338:Everolimus; D005260:Female; D005602:France / Q000453:epidemiology; D006084:Graft Rejection / Q000209:etiology / Q000517:prevention & control; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015994:Incidence; D007677:Kidney Function Tests; D016030:Kidney Transplantation / Q000009:adverse effects* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors; D023001:Transplantation Tolerance / Q000187:drug effects; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus