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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

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

Recruiting
18 years and older
All
Phase 3
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Overview

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.

Description

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.

Eligibility

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.

Study details
    Delayed Graft Function
    DGF
    Kidney Transplant

NCT06830798

Alexion Pharmaceuticals, Inc.

1 November 2025

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