Clinical Trial

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

Study acronym: AWAKE
Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The primary objective of this study is to demonstrate the efficacy of ravulizumab vs placebo in reducing the severity of DGF as measured by time to freedom from dialysis in adult participants who are at high risk of DGF after undergoing transplant of deceased donor kidney.
Protocol Amendment History 2 changes
notable Primary completion moved earlier: 2028-02-04 -> 2027-11-30 2026-06-19
minor Completion moved earlier: 2028-11-06 -> 2028-08-30 2026-06-19
Trial Details
NCT Number NCT06830798
Lead Sponsor Alexion Pharmaceuticals, Inc.
Conditions Delayed Graft Function, DGF, Kidney Transplant
Enrollment 450 participants
Start Date 2025-05-19
Primary Completion 2027-11-30 (estimated)
Study Completion 2028-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-18