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)

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplant; Delayed Graft Function; DGF
• Intervention / Treatment: Drug: Ravulizumab; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 450
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alexion Pharmaceuticals, Inc. (Sponsor); Phone Number: 1-855-752-2356; Email: clinicaltrials@alexion.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1431FWO
    • Recruiting
    • Research Site
  • Buenos Aires, Argentina, 1425
    • Recruiting
    • Research Site
  • Buenos Aires, Argentina, B1629AHJ
    • Recruiting
    • Research Site
  • Capital Federal, Argentina, C1155ADP
    • Not yet recruiting
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  • Córdoba, Argentina, X5016LIG
    • Recruiting
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• Australia
  • Adelaide, Australia, 5000
    • Recruiting
    • Research Site
  • Brisbane, Australia, 4102
    • Recruiting
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  • Camperdown, Australia, 2050
    • Recruiting
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  • Murdoch, Australia, 6150
    • Recruiting
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• Austria
  • Innsbruck, Austria, 6020
    • Recruiting
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  • Vienna, Austria, 1090
    • Recruiting
    • Research Site
• Brazil
  • Belo Horizonte, Brazil, 30150-221
    • Recruiting
    • Research Site
  • Belo Horizonte, Brazil, 30130-100
    • Recruiting
    • Research Site
  • Botucatu, Brazil, 18618-970
    • Recruiting
    • Research Site
  • Botucatu, Brazil, 18618-970
    • Withdrawn
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  • Campinas, Brazil, 13083
    • Recruiting
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  • Fortaleza, Brazil, 60175295
    • Recruiting
    • Research Site
  • Porto Alegre, Brazil, 90035-903
    • Recruiting
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  • Porto Alegre, Brazil, 90050-170
    • Recruiting
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  • Recife, Brazil, 50070-550
    • Recruiting
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  • Rio de Janeiro, Brazil, 1033
    • Recruiting
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  • São José do Rio Preto, Brazil, 15090-000
    • Recruiting
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  • São Paulo, Brazil, 04036-002
    • Recruiting
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• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2E1
      • Recruiting
      • Research Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Recruiting
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  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Not yet recruiting
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    • Toronto, Ontario, Canada, M5B 1W8
      • Recruiting
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  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Not yet recruiting
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• China
  • Guangzhou, China, 510280
    • Recruiting
    • Research Site
  • Guangzhou, China, 510080
    • Recruiting
    • Research Site
  • Guangzhou, China, 510260
    • Recruiting
    • Research Site
  • Hangzhou, China, 310015
    • Recruiting
    • Research Site
  • Hengyang, China, 441021
    • Recruiting
    • Research Site
  • Nanning, China, 530007
    • Recruiting
    • Research Site
  • Shenzhen, China, 518020
    • Recruiting
    • Research Site
  • Taiyuan, China, 030032
    • Not yet recruiting
    • Research Site
  • Taiyuan, China, 030032
    • Withdrawn
    • Research Site
  • Tianjin, China, 300192
    • Recruiting
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  • Zhengzhou, China, 450003
    • Recruiting
    • Research Site
• Czechia
  • Hradec Kralova, Czechia, 50005
    • Recruiting
    • Research Site
  • Ostrava, Czechia, 708 52
    • Recruiting
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  • Prague, Czechia, 140 21
    • Recruiting
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• France
  • Créteil, France, 94000
    • Withdrawn
    • Research Site
  • La Rochelle, France, 17019
    • Withdrawn
    • Research Site
  • La Tronche, France, 38700
    • Withdrawn
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  • Montpellier, France, 34295
    • Not yet recruiting
    • Research Site
  • Nantes, France, 44093
    • Withdrawn
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  • Paris, France, 75651
    • Withdrawn
    • Research Site
  • Toulouse, France, 31059
    • Not yet recruiting
    • Research Site
• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Research Site
  • Erlangen, Germany, 91054
    • Recruiting
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  • Lübeck, Germany, 23538
    • Recruiting
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  • Mainz Am Rhein, Germany, 55131
    • Recruiting
    • Research Site
  • Münster, Germany, 48149
    • Recruiting
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• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Research Site
  • Milan, Italy, 20122
    • Recruiting
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  • Milan, Italy, 20162
    • Recruiting
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  • Padova, Italy, 35128
    • Recruiting
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  • Parma, Italy, 43100
    • Recruiting
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  • Torino, Italy, 10126
    • Recruiting
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• Japan
  • Kyoto, Japan, 602-8566
    • Recruiting
    • Research Site
  • Suita-shi, Japan, 565-0871
    • Recruiting
    • Research Site
• Poland
  • Bydgoszcz, Poland, 85-094
    • Withdrawn
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  • Gdansk, Poland, 80-214
    • Recruiting
    • Research Site
  • Poznan, Poland, 60-355
    • Recruiting
    • Research Site
  • Warsaw, Poland, 02-091
    • Not yet recruiting
    • Research Site
• Portugal
  • Lisbon, Portugal, 1649-035
    • Not yet recruiting
    • Research Site
  • Lisbon, Portugal, 1499-005
    • Recruiting
    • Research Site
  • Lisbon, Portugal, 1069-166
    • Recruiting
    • Research Site
  • Porto, Portugal, 4200319
    • Recruiting
    • Research Site
  • Porto, Portugal, 4050-313
    • Recruiting
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• South Korea
  • Gyeonggi-do, South Korea, 13620
    • Recruiting
    • Research Site
  • Seoul, South Korea, 03080
    • Recruiting
    • Research Site
  • Seoul, South Korea, 03722
    • Recruiting
    • Research Site
• Spain
  • Badajoz, Spain, 06080
    • Recruiting
    • Research Site
  • Barakaldo, Spain, 48903
    • Recruiting
    • Research Site
  • Barcelona, Spain, 08907
    • Not yet recruiting
    • Research Site
  • Barcelona, Spain, 08035
    • Recruiting
    • Research Site
  • Barcelona, Spain, 08036
    • Recruiting
    • Research Site
  • Barcelona, Spain, 8003
    • Recruiting
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  • Barcelona, Spain, 08025
    • Recruiting
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  • Cadiz, Spain, 11009
    • Recruiting
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  • Córdoba, Spain, 14004
    • Recruiting
    • Research Site
  • Granada, Spain, 18014
    • Recruiting
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  • Madrid, Spain, 28041
    • Recruiting
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  • Málaga, Spain, 29010
    • Recruiting
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  • Valencia, Spain, 46017
    • Recruiting
    • Research Site
  • Valencia, Spain, 46009
    • Recruiting
    • Research Site
  • Zaragoza, Spain, 50009
    • Recruiting
    • Research Site
• Taiwan
  • Kaohsiung City, Taiwan, 833
    • Recruiting
    • Research Site
  • Taichung, Taiwan, 40447
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 110
    • Recruiting
    • Research Site
  • Taoyuan District, Taiwan, 333
    • Not yet recruiting
    • Research Site
• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • Recruiting
    • Research Site
  • London, United Kingdom, SE1 9RT
    • Recruiting
    • Research Site
  • London, United Kingdom, NW3 2QG
    • Recruiting
    • Research Site
  • London, United Kingdom, E1 1BB
    • Recruiting
    • Research Site
  • Woodville South, United Kingdom, 5011
    • Recruiting
    • Research Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Research Site
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • Research Site
    • San Francisco, California, United States, 94143
      • Recruiting
      • Research Site
    • San Francisco, California, United States, 94115
      • Withdrawn
      • Research Site
    • Stanford, California, United States, 94305
      • Recruiting
      • Research Site
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Research Site
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Research Site
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • Research Site
    • Chicago, Illinois, United States, 60608
      • Recruiting
      • Research Site
  • Kansas
    • Fairway, Kansas, United States, 66205
      • Recruiting
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  • Kentucky
    • Lexington, Kentucky, United States, 40508
      • Recruiting
      • Research Site
  • Louisiana
    • Kenner, Louisiana, United States, 70065
      • Recruiting
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  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • Research Site
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Research Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
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  • Missouri
    • St Louis, Missouri, United States, 63108
      • Recruiting
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  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • Research Site
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Recruiting
      • Research Site
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Research Site
    • New York, New York, United States, 10016
      • Withdrawn
      • Research Site
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Research Site
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Recruiting
      • Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Research Site
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • Research Site
    • Houston, Texas, United States, 77030
      • Recruiting
      • Research Site
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • Research Site
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Research Site
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Research Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ravulizumab; Participants will receive an IV dose of ravulizumab.	Drug: Ravulizumab; Participants will receive ravulizumab via intravenous (IV) infusion.
Placebo Comparator: Placebo; Participants will receive an IV dose of placebo.	Drug: Placebo; Participants will receive placebo via intravenous (IV) infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to Freedom from Dialysis	Through 90 days post-transplant

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Alexion Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Estimated): February 4, 2028
• Study Completion (Estimated): November 6, 2028

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Kidney Transplant; Ravulizumab; Delayed Graft Function; DGF
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Delayed Graft Function; Substandard Drugs; Pharmaceutical Preparations; ravulizumab
• Other Study ID Numbers: D928EC00001; 2024-517568-48 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No