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

Authors

William H Marks, Anup Patel, Ondrej Viklicky, Denis Glotz, Lloyd E Ratner, Flavio Vincenti, Josep M Cruzado, Sanela Tarabar Galijasevic, Xiaoyu Jiang, Masayo Ogawa, Hermann Haller, Francesc Moreso, Rostand Emmanuel Nguefouet Momo, Richard N Formica, John S Gill, William Irish

Published in

American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons. Sep 19, 2026. Epub Sep 19, 2026.

Abstract

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.

PMID:
42763038
Bibliographic data and abstract were imported from PubMed on 20 Sep 2026.

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