A 3-month, multicenter, randomized, open-label study to evaluate the impact on wound healing of the early (vs delayed) introduction of everolimus in De Novo Kidney transplant recipients, with a follow-up evaluation at 12 months after transplant (NEVERWOUND study)

Gionata Spagnoletti, Tommaso Maria Manzia, Mario Carmellini, Paola Todeschini, Antonio Secchi, Silvio Sandrini, Enrico Minetti, Lucrezia Furian, Francesco Pisani, Gian Benedetto Piredda, Gianni Cappelli, Giuseppe Tisone

Risultato della ricerca: Contributo in rivistaArticolo in rivista

1 Citazioni (Scopus)

Abstract

Background. The risk of wound healing complications (WHCs) and the early use of mammalian target of rapamycin inhibitors after kidney transplantation (KT) have not been fully addressed. Methods. The NEVERWOUND study is a 3-month, multicenter, randomized, open-label study designed to evaluate whether a delayed (ie, 28 ± 4 d posttransplant) immunosuppression regimen based on everolimus (EVR) reduces the risk of WHC versus EVR started immediately after KT. Secondary endpoints were treatment failure (biopsy-proven acute rejection, graft loss, or death), delayed graft function, patient and graft survival rates, and renal function. Results. Overall, 394 KT recipients were randomized to receive immediate (N = 197) or delayed (N = 197) EVR after KT. At 3 months, WHC-free rates in the immediate EVR versus delayed EVR arm, considering the worst- and best-case scenario approach, were 0.68 (95% confidence interval [CI], 0.62-0.75) versus 0.62 (95% CI, 0.55-0.68) (log-rank P = 0.56) and 0.70 (95% CI, 0.64-0.77) versus 0.72 (95% CI, 0.65-0.78) (log-rank P = 0.77), respectively. The 3- and 12-month treatment failure rates, delayed graft function and renal function, and patient and graft survival were not different between the arms. Conclusions. The early introduction of EVR after KT did not increase the risk of WHC, showing good efficacy and safety profile.
Lingua originaleEnglish
pagine (da-a)374-386
Numero di pagine13
RivistaTransplantation
Volume104
DOI
Stato di pubblicazionePubblicato - 2020
Pubblicato esternamente

Keywords

  • kidney transplant

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