BACKGROUND: The risk of Wound Healing Complications (WHC) and the early use of mTORi 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 (i.e. 28 ± 4 days post-transplant) immunosuppression regimen based on everolimus (EVR) reduces the risk of WHC vs EVR started immediately after KT. Secondary endpoints were: treatment failure (biopsy-proven acute rejection, graft loss or death); Delayed Graft Function (DGF); patient and graft survival rates; renal function. RESULTS: Overall, 394 KT recipients were randomized to receive immediate (N=197, IE) or delayed (N=197; DE) EVR after KT. At 3 months, WHC-free rates in the IE vs DE arm, considering the worst- and best-case scenario approach, were 0.68 (95% CI 0.62-0.75) vs 0.62 (95% CI 0.55-0.68)(log-rank p=0.56) and 0.70 (95% CI 0.64-0.77) vs 0.72 (95% CI 0.65-0.78 (log-rank=0.77), respectively. The 3- and 12-month treatment failure rates, DGF and renal function, as well as patient and graft survival, were not different between the arms. CONCLUSION: The early introduction of EVR after KT did not increase the risk of WHC, showing good efficacy and safety profile.

Manzia, T.M., Carmellini, M., Todeschini, P., Secchi, A., Sandrini, S., Minetti, E., et al. (2020). 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 month after transplant (NEVERWOUND study). TRANSPLANTATION, 104(2), 374-386 [10.1097/TP.0000000000002851].

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 month after transplant (NEVERWOUND study)

Carmellini, Mario;
2020-01-01

Abstract

BACKGROUND: The risk of Wound Healing Complications (WHC) and the early use of mTORi 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 (i.e. 28 ± 4 days post-transplant) immunosuppression regimen based on everolimus (EVR) reduces the risk of WHC vs EVR started immediately after KT. Secondary endpoints were: treatment failure (biopsy-proven acute rejection, graft loss or death); Delayed Graft Function (DGF); patient and graft survival rates; renal function. RESULTS: Overall, 394 KT recipients were randomized to receive immediate (N=197, IE) or delayed (N=197; DE) EVR after KT. At 3 months, WHC-free rates in the IE vs DE arm, considering the worst- and best-case scenario approach, were 0.68 (95% CI 0.62-0.75) vs 0.62 (95% CI 0.55-0.68)(log-rank p=0.56) and 0.70 (95% CI 0.64-0.77) vs 0.72 (95% CI 0.65-0.78 (log-rank=0.77), respectively. The 3- and 12-month treatment failure rates, DGF and renal function, as well as patient and graft survival, were not different between the arms. CONCLUSION: The early introduction of EVR after KT did not increase the risk of WHC, showing good efficacy and safety profile.
Manzia, T.M., Carmellini, M., Todeschini, P., Secchi, A., Sandrini, S., Minetti, E., et al. (2020). 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 month after transplant (NEVERWOUND study). TRANSPLANTATION, 104(2), 374-386 [10.1097/TP.0000000000002851].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11365/1077831