Phase 3 Trial of Intravenous Ravulizumab to Reduce Delayed Graft Function in Adults at High Risk After Deceased Donor Kidney Transplant

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ravulizumab compared to placebo in adult patients at high risk of delayed graft function DGF following deceased donor kidney transplantation. The study aims to show whether ravulizumab can reduce the severity of DGF, specifically by shortening the time patients need dialysis after transplant. This phase 3, randomized, double-blind trial focuses on patients with dialysis-dependent end-stage kidney disease receiving kidneys from specific donor types. Participants will be randomly assigned to one of two groups one receiving intravenous infusions of ravulizumab, and the other receiving placebo infusions. The treatment is given intravenously, and participants receive either the study drug or placebo throughout the study. The trial compares these groups to assess the impact on DGF. The study is conducted across multiple centers and follows participants through 90 days after transplantation to measure outcomes. Throughout the study, participants will undergo regular assessments to monitor their kidney function and dialysis needs. Researchers will measure the time until participants no longer require dialysis, the number of dialysis sessions needed, the incidence of DGF within 7 days post-transplant, and kidney function as measured by eGFR. Safety and efficacy data are collected during the post-transplant period, with primary outcome measurements taken through 90 days after transplant. The total participation period extends until the studys completion in 2028.

Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation