A Phase 3, 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
A Phase 3, 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
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.
AWAKE is a multicenter, prospective study to evaluate the safety and efficacy of ravulizumab in reducing delayed graft function (DGF) in kidney transplant recipients at high risk for DGF. Eligible participants will be randomized in a 1:1 ratio to receive either ravulizumab or placebo intravenously.
Inclusion Criteria:
≥ 18 years of age at the time of signing the informed consent
Diagnosed with Dialysis-dependent End-Stage Kidney Disease (ESKD)
A candidate for kidney transplant from:
Exclusion Criteria:
clinicaltrials@alexion.com1-855-752-2356
Capital Federal, C1155ADP, Argentina
Hradec Kralova, 50005, Czechia
Mainz Am Rhein, 55131, Germany
Suita-shi, 565-0871, Japan
Woodville South, 5011, United Kingdom