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
Status: Recruiting
Location: See all (125) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥ 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:
‣ Donation after Circulatory Death (DCD) donor
⁃ High-risk Donation after Brain Death (DBD) donor
Locations
United States
Arizona
Research Site
RECRUITING
Phoenix
California
Research Site
RECRUITING
Los Angeles
Research Site
NOT_YET_RECRUITING
San Francisco
Research Site
WITHDRAWN
San Francisco
Research Site
NOT_YET_RECRUITING
Stanford
Connecticut
Research Site
RECRUITING
New Haven
Florida
Research Site
RECRUITING
Jacksonville
Research Site
RECRUITING
Tampa
Georgia
Research Site
RECRUITING
Atlanta
Illinois
Research Site
RECRUITING
Chicago
Research Site
NOT_YET_RECRUITING
Chicago
Kansas
Research Site
NOT_YET_RECRUITING
Fairway
Kentucky
Research Site
RECRUITING
Lexington
Louisiana
Research Site
RECRUITING
Kenner
Michigan
Research Site
RECRUITING
Ann Arbor
Research Site
RECRUITING
Detroit
Minnesota
Research Site
NOT_YET_RECRUITING
Minneapolis
Missouri
Research Site
NOT_YET_RECRUITING
St Louis
North Carolina
Research Site
RECRUITING
Durham
Nebraska
Research Site
NOT_YET_RECRUITING
Omaha
New Jersey
Research Site
RECRUITING
Livingston
New York
Research Site
WITHDRAWN
New York
Research Site
RECRUITING
New York
Pennsylvania
Research Site
RECRUITING
Philadelphia
South Carolina
Research Site
RECRUITING
Greenville
Tennessee
Research Site
RECRUITING
Nashville
Texas
Research Site
RECRUITING
Dallas
Research Site
RECRUITING
Houston
Virginia
Research Site
NOT_YET_RECRUITING
Charlottesville
Research Site
RECRUITING
Richmond
Washington
Research Site
RECRUITING
Seattle
Wisconsin
Research Site
RECRUITING
Milwaukee
Other Locations
Argentina
Research Site
NOT_YET_RECRUITING
Buenos Aires
Research Site
NOT_YET_RECRUITING
Buenos Aires
Research Site
NOT_YET_RECRUITING
Buenos Aires
Research Site
NOT_YET_RECRUITING
Capital Federal
Research Site
NOT_YET_RECRUITING
Córdoba
Australia
Research Site
RECRUITING
Adelaide
Research Site
RECRUITING
Brisbane
Research Site
RECRUITING
Camperdown
Research Site
NOT_YET_RECRUITING
Murdoch
Austria
Research Site
NOT_YET_RECRUITING
Innsbruck
Research Site
RECRUITING
Vienna
Brazil
Research Site
RECRUITING
Belo Horizonte
Research Site
RECRUITING
Belo Horizonte
Research Site
RECRUITING
Botucatu
Research Site
NOT_YET_RECRUITING
Campinas
Research Site
RECRUITING
Fortaleza
Research Site
RECRUITING
Porto Alegre
Research Site
RECRUITING
Porto Alegre
Research Site
RECRUITING
Recife
Research Site
NOT_YET_RECRUITING
Rio De Janeiro
Research Site
RECRUITING
São José Do Rio Preto
Research Site
RECRUITING
São Paulo
Canada
Research Site
NOT_YET_RECRUITING
Edmonton
Research Site
NOT_YET_RECRUITING
Toronto
Research Site
NOT_YET_RECRUITING
Toronto
Research Site
RECRUITING
Vancouver
China
Research Site
NOT_YET_RECRUITING
Guangzhou
Research Site
NOT_YET_RECRUITING
Guangzhou
Research Site
NOT_YET_RECRUITING
Guangzhou
Research Site
NOT_YET_RECRUITING
Hangzhou
Research Site
NOT_YET_RECRUITING
Hengyang
Research Site
NOT_YET_RECRUITING
Nanning
Research Site
NOT_YET_RECRUITING
Shenzhen
Research Site
WITHDRAWN
Taiyuan
Research Site
NOT_YET_RECRUITING
Taiyuan
Research Site
NOT_YET_RECRUITING
Tianjin
Research Site
NOT_YET_RECRUITING
Zhengzhou
France
Research Site
NOT_YET_RECRUITING
Créteil
Research Site
NOT_YET_RECRUITING
La Rochelle
Research Site
NOT_YET_RECRUITING
La Tronche
Research Site
NOT_YET_RECRUITING
Montpellier
Research Site
NOT_YET_RECRUITING
Nantes
Research Site
NOT_YET_RECRUITING
Paris
Research Site
NOT_YET_RECRUITING
Toulouse
Germany
Research Site
NOT_YET_RECRUITING
Berlin
Research Site
NOT_YET_RECRUITING
Erlangen
Research Site
NOT_YET_RECRUITING
Lübeck
Research Site
NOT_YET_RECRUITING
Mainz Am Rhein
Research Site
RECRUITING
Münster
Italy
Research Site
RECRUITING
Bologna
Research Site
NOT_YET_RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Milan
Research Site
NOT_YET_RECRUITING
Padua
Research Site
NOT_YET_RECRUITING
Parma
Research Site
NOT_YET_RECRUITING
Torino
Japan
Research Site
NOT_YET_RECRUITING
Kyoto
Research Site
RECRUITING
Suita-shi
Poland
Research Site
WITHDRAWN
Bydgoszcz
Research Site
NOT_YET_RECRUITING
Gdansk
Research Site
NOT_YET_RECRUITING
Poznan
Research Site
NOT_YET_RECRUITING
Warsaw
Portugal
Research Site
NOT_YET_RECRUITING
Lisbon
Research Site
RECRUITING
Lisbon
Research Site
NOT_YET_RECRUITING
Lisbon
Research Site
RECRUITING
Porto
Research Site
NOT_YET_RECRUITING
Porto
Republic of Korea
Research Site
RECRUITING
Gyeonggi-do
Research Site
NOT_YET_RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Spain
Research Site
RECRUITING
Badajoz
Research Site
NOT_YET_RECRUITING
Barakaldo
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Barcelona
Research Site
NOT_YET_RECRUITING
Cadiz
Research Site
RECRUITING
Córdoba
Research Site
RECRUITING
Granada
Research Site
RECRUITING
Madrid
Research Site
RECRUITING
Málaga
Research Site
RECRUITING
Valencia
Research Site
NOT_YET_RECRUITING
Valencia
Research Site
NOT_YET_RECRUITING
Zaragoza
Taiwan
Research Site
NOT_YET_RECRUITING
Kaohsiung City
Research Site
NOT_YET_RECRUITING
Taichung
Research Site
RECRUITING
Taipei
Research Site
NOT_YET_RECRUITING
Taoyuan District
United Kingdom
Research Site
NOT_YET_RECRUITING
Leeds
Research Site
NOT_YET_RECRUITING
London
Research Site
NOT_YET_RECRUITING
London
Research Site
NOT_YET_RECRUITING
London
Research Site
RECRUITING
Woodville South
Contact Information
Primary
Alexion Pharmaceuticals, Inc. (Sponsor)
clinicaltrials@alexion.com
1-855-752-2356
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2028-11-06
Participants
Target number of participants: 450
Treatments
Experimental: Ravulizumab
Participants will receive an IV dose of ravulizumab.
Placebo_comparator: Placebo
Participants will receive an IV dose of placebo.
Related Therapeutic Areas
Sponsors
Leads: Alexion Pharmaceuticals, Inc.