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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
Sponsor: Alexion Pharmaceuticals, Inc.
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.
Official 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2025-05-19
Completion Date
2028-11-06
Last Updated
2026-04-07
Healthy Volunteers
No
Interventions
Ravulizumab
Participants will receive ravulizumab via intravenous (IV) infusion.
Placebo
Participants will receive placebo via intravenous (IV) infusion.
Locations (130)
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Phoenix, Arizona, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Stanford, California, United States
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New Haven, Connecticut, United States
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Jacksonville, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Fairway, Kansas, United States
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Lexington, Kentucky, United States
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Kenner, Louisiana, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Omaha, Nebraska, United States
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Livingston, New Jersey, United States
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New York, New York, United States
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New York, New York, United States
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Durham, North Carolina, United States
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Philadelphia, Pennsylvania, United States
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Greenville, South Carolina, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Charlottesville, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Capital Federal, Argentina
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Adelaide, Australia
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Camperdown, Australia
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Murdoch, Australia
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Innsbruck, Austria
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Vienna, Austria
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Belo Horizonte, Brazil
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Belo Horizonte, Brazil
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Botucatu, Brazil
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Botucatu, Brazil
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Campinas, Brazil
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Fortaleza, Brazil
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Recife, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Guangzhou, China
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Hangzhou, China
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Hengyang, China
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Nanning, China
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Shenzhen, China
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Taiyuan, China
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Taiyuan, China
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Tianjin, China
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Zhengzhou, China
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Hradec Kralova, Czechia
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Ostrava, Czechia
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Prague, Czechia
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Créteil, France
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La Rochelle, France
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Paris, France
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Mainz Am Rhein, Germany
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Porto, Portugal
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Porto, Portugal
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Seoul, South Korea
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Seoul, South Korea
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Badajoz, Spain
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Barakaldo, Spain
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Cadiz, Spain
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Valencia, Spain
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Valencia, Spain
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Zaragoza, Spain
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Leeds, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Woodville South, United Kingdom