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)

April 27, 2026 updated by: Alexion Pharmaceuticals, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Research Site
      • Córdoba, Argentina, X5016LIG
        • Recruiting
        • Research Site
  • Australia
      • Adelaide, Australia, 5000
        • Recruiting
        • Research Site
      • Brisbane, Australia, 4102
        • Recruiting
        • Research Site
      • Camperdown, Australia, 2050
        • Recruiting
        • Research Site
      • Murdoch, Australia, 6150
        • Recruiting
        • Research Site
  • Austria
      • Innsbruck, Austria, 6020
        • Recruiting
        • Research Site
      • 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
        • Research Site
      • Campinas, Brazil, 13083
        • Recruiting
        • Research Site
      • Fortaleza, Brazil, 60175295
        • Recruiting
        • Research Site
      • Porto Alegre, Brazil, 90035-903
        • Recruiting
        • Research Site
      • Porto Alegre, Brazil, 90050-170
        • Recruiting
        • Research Site
      • Recife, Brazil, 50070-550
        • Recruiting
        • Research Site
      • Rio de Janeiro, Brazil, 1033
        • Recruiting
        • Research Site
      • São José do Rio Preto, Brazil, 15090-000
        • Recruiting
        • Research Site
      • São Paulo, Brazil, 04036-002
        • Recruiting
        • Research Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • Recruiting
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Research Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Not yet recruiting
        • Research Site
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Not yet recruiting
        • Research Site
  • 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
        • Research Site
      • Zhengzhou, China, 450003
        • Recruiting
        • Research Site
  • Czechia
      • Hradec Kralova, Czechia, 50005
        • Recruiting
        • Research Site
      • Ostrava, Czechia, 708 52
        • Recruiting
        • Research Site
      • Prague, Czechia, 140 21
        • Recruiting
        • Research Site
  • France
      • Créteil, France, 94000
        • Withdrawn
        • Research Site
      • La Rochelle, France, 17019
        • Withdrawn
        • Research Site
      • La Tronche, France, 38700
        • Withdrawn
        • Research Site
      • Montpellier, France, 34295
        • Not yet recruiting
        • Research Site
      • Nantes, France, 44093
        • Withdrawn
        • Research Site
      • 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
        • Research Site
      • Lübeck, Germany, 23538
        • Recruiting
        • Research Site
      • Mainz Am Rhein, Germany, 55131
        • Recruiting
        • Research Site
      • Münster, Germany, 48149
        • Recruiting
        • Research Site
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Research Site
      • Milan, Italy, 20122
        • Recruiting
        • Research Site
      • Milan, Italy, 20162
        • Recruiting
        • Research Site
      • Padova, Italy, 35128
        • Recruiting
        • Research Site
      • Parma, Italy, 43100
        • Recruiting
        • Research Site
      • Torino, Italy, 10126
        • Recruiting
        • Research Site
  • Japan
      • Kyoto, Japan, 602-8566
        • Recruiting
        • Research Site
      • Suita-shi, Japan, 565-0871
        • Recruiting
        • Research Site
  • Poland
      • Bydgoszcz, Poland, 85-094
        • Withdrawn
        • Research Site
      • 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
        • Research Site
  • 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
        • Research Site
      • Barcelona, Spain, 08025
        • Recruiting
        • Research Site
      • Cadiz, Spain, 11009
        • Recruiting
        • Research Site
      • Córdoba, Spain, 14004
        • Recruiting
        • Research Site
      • Granada, Spain, 18014
        • Recruiting
        • Research Site
      • Madrid, Spain, 28041
        • Recruiting
        • Research Site
      • Málaga, Spain, 29010
        • Recruiting
        • Research Site
      • 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
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • Recruiting
        • Research Site
    • Louisiana
      • Kenner, Louisiana, United States, 70065
        • Recruiting
        • Research Site
    • 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
        • Research Site
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Recruiting
        • Research Site
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Time to Freedom from Dialysis
Time Frame: Through 90 days post-transplant
Through 90 days post-transplant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
DGF Incidence
Time Frame: Up to 7 days post-transplant
Up to 7 days post-transplant
Number of Dialysis Sessions
Time Frame: Through 90 days post-transplant
Through 90 days post-transplant
Time to Occurrence of eGFR reaching 30 mL/min/1.73 m2
Time Frame: Through 90 days post-transplant
Through 90 days post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexion Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 6, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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