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
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
≥ 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:
1. Donation after Circulatory Death (DCD) donor
2. High-risk Donation after Brain Death (DBD) donor
You may not be if
Is to receive a kidney from a donor with category I,II,IV and V Maastricht Classification
Diagnosed with Acute Kidney Injury (AKI) of Stage 3 severity according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.
Clareo Health | 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
