Incidence of delayed graft function and wound healing complications after deceased-donor kidney transplantation is not affected by de novo everolimus.
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.
Albano
Laetitia
L
Service de Néphrologie et Transplantation Rénale, Hôpital Pasteur, Nice, France.
Berthoux
François
F
Moal
Marie-Christine
MC
Rostaing
Lionel
L
Legendre
Christophe
C
Genin
Robert
R
Toupance
Olivier
O
Moulin
Bruno
B
Merville
Pierre
P
Rerolle
Jean-Philippe
JP
Bayle
François
F
Westeel
Pierre François
PF
Glotz
Denis
D
Kossari
Niloufar
N
Lefrançois
Nicole
N
Charpentier
Bernard
B
Blanc
Anne-Sandrine
AS
Di Giambattista
Fabienne
F
Dantal
Jacques
J
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*
D007166:Immunosuppressive Agents; D000068338:Everolimus; D020123:Sirolimus