Date: Sunday, June 12, 2016
Session Time: 2:30pm-4:00pm
Presentation Time: 3:30pm-3:42pm
Location: Room 312
The NEVERWOUND study was designed to evaluate the impact of immediate vs. delayed introduction of everolimus (EVR) on wound healing complications (WHC) and delayed graft function (DGF) in de novo kidney transplant (Tx) recipients during the first 3 months post-Tx.
NEVERWOUND (NCT01410448), an open-label, multicenter study randomized 383 single kidney Tx recipients to: immediate EVR (0.75 mg twice daily), within 48 hours after graft reperfusion (N=193; iEVR) along with low-dose cyclosporine (CsA, 4 mg/kg/day) or delayed EVR (0.75 mg twice daily) 28±4 days after Tx (N=190; dEVR) along with low-dose CsA, with a bridge of enteric-coated mycophenolate sodium (1440 mg/day) and CsA (6–8 mg/kg/day). All patients received induction therapy and steroids as per local clinical practice. Primary endpoint is the proportion of patients without WHC related to initial transplant surgery (i.e. lymphorrea, fluid collections, wound dehiscence, wound infections, incisional hernia). Secondary endpoints are the rate of treatment failure (composite endpoint: biopsy-proven acute rejection, graft loss, death), incidence and duration of DGF, patient and graft survival rates, renal function and proteinuria.
Proportion of patients without any WHC at 3 months was 70.5% and 72.1% in iEVR and dEVR groups respectively (p=0.67). Among different complication types, comparable rates were observed for the two treatment groups (p=NS). Treatment failure rate was 8.3% and 6.8% in iEVR and dEVR groups respectively (p=0.57). DGF occurrence was 23.8% and 31.6% (p=0.12) with a median duration of 8.5 and 5.5 days of dialysis in iEVR and dEVR groups respectively (p=0.21). No differences between the two groups were observed regarding patient (p=0.66) and graft survival rates (p=0.36), renal function and proteinuria.
The immediate introduction of EVR post-Tx did not increase the risk of WHC and showed DGF incidence and duration comparable to delayed introduction. Renal function, efficacy, safety and tolerability were similar with both treatment groups.
CITATION INFORMATION: Carmellini M, Todeschini P, Secchi A, Sandrini S, Minetti E, Furian L, Spagnoletti G, Pisani F, Piredda G, Cappelli G, Tisone G. Immediate Introduction of Everolimus Does Not Affect Wound Healing and Delayed Graft Function in Kidney Transplant Recipients: 3-Months Results from NEVERWOUND Study. Am J Transplant. 2016;16 (suppl 3).
To cite this abstract in AMA style:Carmellini M, Todeschini P, Secchi A, Sandrini S, Minetti E, Furian L, Spagnoletti G, Pisani F, Piredda G, Cappelli G, Tisone G. Immediate Introduction of Everolimus Does Not Affect Wound Healing and Delayed Graft Function in Kidney Transplant Recipients: 3-Months Results from NEVERWOUND Study. [abstract]. Am J Transplant. 2016; 16 (suppl 3). http://atcmeetingabstracts.com/abstract/immediate-introduction-of-everolimus-does-not-affect-wound-healing-and-delayed-graft-function-in-kidney-transplant-recipients-3-months-results-from-neverwound-study/. Accessed November 19, 2017.
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