Evaluation of eculizumab for the prevention of delayed graft function after kidney transplantation in adults: A randomized, double-blind, placebo-controlled trial
In brief
Eculizumab did not cut delayed graft function rates in kidney transplants
In a double-blind trial of 288 adult deceased-donor kidney recipients, delayed graft function occurred in 35.9% of patients receiving eculizumab versus 41.7% with placebo-a modest 6% absolute drop that was not statistically significant. Post-hoc analysis hinted a larger benefit (about 18% fewer cases) in recipients of expanded-criteria, cold-stored kidneys, but this finding requires confirmation.
- Journal
- American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons (Q1)
- Published
- 19 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- William H Marks, Anup Patel, Ondrej Viklicky, Denis Glotz, Lloyd E Ratner, Flavio Vincenti, et al.
- PMID
- 42763038
- DOI
- 10.1016/j.ajt.2026.09.024
Why clinicians should know about it
- Picked for Transplantation (paper of the day, 20 September 2026): RCT of eculizumab for delayed graft function
- Picked for Nephrology (top studies of the week, 20 September 2026): Randomized, double‑blind, placebo‑controlled trial of eculizumab
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.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.