Evaluation of eculizumab for the prevention of delayed graft function after kidney transplantation in adults: A randomized, double-blind, placebo-controlled trial.

Delayed graft function (DGF), defined as the need for dialysis within the first 7 days post-kidney transplantation, is increasing owing to greater use of expanded criteria donors (ECDs). No approved therapy currently prevents DGF or reduces its severity. Results of a randomized, double-blind, placebo-controlled clinical trial to evaluate eculizumab for the prevention of DGF post-transplantation in adults (aged ≥ 18 years) are presented. In total, 142 patients received eculizumab, and 146 patients received placebo immediately before (eculizumab, 1200 mg, or placebo) and 18-24 hours post-transplantation (eculizumab, 900 mg, or placebo). Eculizumab did not statistically significantly reduce the incidence of DGF in adult deceased donor kidney transplant recipients compared with placebo (n =51/142 [35.9%] vs n=60/144 [41.7%]; treatment difference -5.75% [95% confidence interval -17.03%, 5.52%]). Overall, there were no substantial differences observed in safety results between treatment groups. Post hoc analyses showed patients who received an ECD/cold storage transplant had a -17.8% difference in DGF with eculizumab versus placebo. Although eculizumab did not significantly reduce the incidence of DGF in adult deceased donor kidney transplants, post hoc analyses suggested a treatment benefit in recipients of an ECD kidney managed with cold storage. CLINICAL TRIAL NUMBER: NCT02145182.