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.

• Ravulizumab (Drug): Participants will receive ravulizumab via intravenous (IV) infusion.
• Placebo (Drug): Participants will receive placebo via intravenous (IV) infusion.

Primary outcomes

• Time to Freedom from Dialysis [Through 90 days post-transplant]

Secondary outcomes

• DGF Incidence [Up to 7 days post-transplant]
• Number of Dialysis Sessions [Through 90 days post-transplant]
• Time to Occurrence of eGFR reaching 30 mL/min/1.73 m2 [Through 90 days post-transplant]

Sex: All, ages: 18 Years to any

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:

  1. Donation after Circulatory Death (DCD) donor
  2. High-risk Donation after Brain Death (DBD) donor

Exclusion Criteria:

* 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.

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