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).Manzia, T. M., Carmellini, M. et al. (2019).
Transplantation [record in progress].
This study aimed to evaluate whether the delayed administration of everolimus (28+/-4 days post-transplant) reduces the risk of wound healing complications in de novo kidney transplant patients.
Kidney transplanted patients were randomized (1:1) to either immediate EVR (IE) or delayed EVER (DE) (28+/- 4 days).
394 kidney transplant patients (recruited between Novemer 2011 and December 2015).
The primary outcomes of this study were identified as the presence of wound healing complications; defined as: fluid collection (serum>5cm fluid), prolonged lympahtic drainage (>150 ml/24 hours, 7 days post-transplantation), wound dehiscence, wound infection and incisional hernia (assessed as months 3 and 12). Secondary outcomes were assessed as treatment failure rate (biopsy-proven acute rejection, graft loss, graft death); death-censored graft survival rate, graft survival rate, patient survival rate, incide and duration of delated graft function and kidney function, which was measured as es
The multicentre, open, NEVERWOUND trial compared immediate versus delayed (28±4 days) introduction of everolimus in terms of wound complications in kidney transplant recipients. The study consisted of a 3-month treatment phase followed by a 9-month observation phase during which the study participants were treated according to local practice. Patients were randomised according to a web-based system. The primary endpoint was wound healing complications and the sample size calculation showed that 198 participants per arm were needed to provide 90% power. 394 participants were randomised and 383 participants were included in the intention-to-treat and safety populations. There were no differences in overall wound healing complications between the two arms at 3 and 12 months. The secondary outcomes treatment failure (i.e. death, graft loss, biopsy-proven acute rejection), delayed graft function, renal function, patient and graft survival rates and adverse events were also not different between groups. This trial shows that early introduction of everolimus does not increase the risk of wound healing complications in kidney transplant recipients.
ClinicalTrials.gov - NCT01410448