Incidence of delayed graft function and wound healing complications after deceased-donor kidney transplantation is not affected by de novo everolimus.
Transplantation
; 88(1): 69-76, 2009 Jul 15.
Article
em En
| MEDLINE
| ID: mdl-19584683
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Cicatrização
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Transplante de Rim
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Sirolimo
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Função Retardada do Enxerto
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Imunossupressores
Tipo de estudo:
Clinical_trials
/
Etiology_studies
/
Guideline
/
Incidence_studies
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Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Aged
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Female
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Humans
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Male
/
Middle aged
País/Região como assunto:
Europa
Idioma:
En
Revista:
Transplantation
Ano de publicação:
2009
Tipo de documento:
Article
País de afiliação:
França