TY - JOUR
T1 - 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)
AU - Manzia, Tommaso Maria
AU - Carmellini, Mario
AU - Todeschini, Paola
AU - Secchi, Antonio
AU - Sandrini, Silvio
AU - Minetti, Enrico
AU - Furian, Lucrezia
AU - Spagnoletti, Gionata
AU - Pisani, Francesco
AU - Piredda, Gian Benedetto
AU - Cappelli, Gianni
AU - Tisone, Giuseppe
PY - 2020
Y1 - 2020
N2 - 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.
AB - 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.
KW - kidney transplant
KW - kidney transplant
UR - http://hdl.handle.net/10807/158064
U2 - 10.1097/TP.0000000000002851
DO - 10.1097/TP.0000000000002851
M3 - Article
SN - 0041-1337
VL - 104
SP - 374
EP - 386
JO - Transplantation
JF - Transplantation
ER -