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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06830798




Registration number
NCT06830798
Ethics application status
Date submitted
10/02/2025
Date registered
17/02/2025

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
2024-517568-48
Secondary ID [2] 0 0
D928EC00001
Universal Trial Number (UTN)
Trial acronym
AWAKE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delayed Graft Function 0 0
DGF 0 0
Kidney Transplant 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ravulizumab
Treatment: Drugs - Placebo

Experimental: Ravulizumab - Participants will receive an IV dose of ravulizumab.

Placebo comparator: Placebo - Participants will receive an IV dose of placebo.


Treatment: Drugs: Ravulizumab
Participants will receive ravulizumab via intravenous (IV) infusion.

Treatment: Drugs: Placebo
Participants will receive placebo via intravenous (IV) infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Freedom from Dialysis
Timepoint [1] 0 0
Through 90 days post-transplant
Secondary outcome [1] 0 0
DGF Incidence
Timepoint [1] 0 0
Up to 7 days post-transplant
Secondary outcome [2] 0 0
Number of Dialysis Sessions
Timepoint [2] 0 0
Through 90 days post-transplant
Secondary outcome [3] 0 0
Time to Occurrence of eGFR reaching 30 mL/min/1.73 m2
Timepoint [3] 0 0
Through 90 days post-transplant

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/11/2028
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Brisbane
Recruitment hospital [3] 0 0
Research Site - Camperdown
Recruitment hospital [4] 0 0
Research Site - Murdoch
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4102 - Brisbane
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
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United States of America
State/province [8] 0 0
Kentucky
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United States of America
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Louisiana
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United States of America
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Michigan
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Minnesota
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Missouri
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Nebraska
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New Jersey
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New York
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United States of America
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North Carolina
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Pennsylvania
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United States of America
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South Carolina
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Tennessee
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Texas
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Virginia
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Washington
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Capital Federal
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Argentina
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Córdoba
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Austria
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Innsbruck
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Austria
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Vienna
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Brazil
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Belo Horizonte
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Brazil
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Botucatu
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Brazil
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Bragança Paulista
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Campinas
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Brazil
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Fortaleza
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Porto Alegre
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Recife
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Sao Paulo
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São José do Rio Preto
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Brazil
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São Paulo
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Canada
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Alberta
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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China
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Guangzhou
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China
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Nanning
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China
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Tianjin
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Czechia
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Hradec Kralova
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Czechia
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Ostrava
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Czechia
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Praha 4
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France
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Creteil
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La Rochelle
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France
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La Tronche
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France
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Montpellier cedex 5
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France
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Nantes cedex 1
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France
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Paris Cedex 13
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France
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Toulouse
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Germany
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Berlin
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Germany
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Erlangen
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Germany
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Kiel
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Germany
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Mainz Am Rhein
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Germany
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Muenster
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Bologna
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Foligno
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Padova
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Parma
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Poland
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Bydgoszcz
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Gdansk
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Poznan
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Warszawa
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Portugal
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Lisboa
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Lisbon
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Porto
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Badajoz
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Barakaldo
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Barcelona
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Cádiz
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Córdoba
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Granada
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Madrid
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Málaga
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Valencia
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Spain
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Zaragoza
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Taipei City
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Taiwan
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Taoyuan
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United Kingdom
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Leeds
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United Kingdom
State/province [90] 0 0
London
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Woodville South

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alexion Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alexion Pharmaceuticals, Inc. (Sponsor)
Address 0 0
Country 0 0
Phone 0 0
1-855-752-2356
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06830798