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

Phase 3

Recruiting

• Conditions: Delayed Graft Function; DGF; Kidney Transplant
• Interventions: Drug: Ravulizumab; Drug: Placebo

• Registration Number: NCT06830798
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-12
• Study First Posted: 2025-02-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-21
• Study Start: 2025-05-30
• Primary Completion: 2028-02-14
• Study Completion: 2028-11-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ravulizumab	Ravulizumab	Participants will receive an IV dose of ravulizumab.
Placebo	Placebo	Participants will receive an IV dose of placebo.

Primary Outcome Measures

Name	Time	Method
Time to Freedom from Dialysis	Through 90 days post-transplant

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Woodville South, United Kingdom