What this study is
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.
What's being tested
- Ravulizumab
Intervention · DRUG
Participants will receive ravulizumab via intravenous (IV) infusion.
- Placebo
Intervention · DRUG
Participants will receive placebo via intravenous (IV) infusion.
Study details
- 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
- Sponsor
- Alexion Pharmaceuticals, Inc.
- Conditions
- Delayed Graft Function · DGF · Kidney Transplant
- Enrolling
- 450 people
- Starts
- 2025-05-19
- Est. completion
- 2028-11-06
- Design
- Quadruple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- ≥ 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (130)
120 openResearch Site
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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St Louis, Missouri, 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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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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San Francisco, California, United States
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New York, New York, United States
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98 sites outside the US
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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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Córdoba, Argentina
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Adelaide, Australia
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Brisbane, 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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Campinas, Brazil
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Fortaleza, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Recife, Brazil
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Rio de Janeiro, Brazil
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São José do Rio Preto, 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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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Guangzhou, China
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Guangzhou, China
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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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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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Montpellier, France
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Toulouse, France
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Berlin, Germany
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Erlangen, Germany
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Lübeck, Germany
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Mainz Am Rhein, Germany
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Münster, Germany
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Bologna, Italy
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Milan, Italy
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Milan, Italy
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Padova, Italy
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Parma, Italy
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Torino, Italy
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Kyoto, Japan
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Suita-shi, Japan
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Gdansk, Poland
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Poznan, Poland
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Warsaw, Poland
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Lisbon, Portugal
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Lisbon, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Porto, Portugal
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Gyeonggi-do, South Korea
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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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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Cadiz, Spain
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Córdoba, Spain
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Granada, Spain
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Madrid, Spain
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Málaga, 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
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Botucatu, Brazil
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Taiyuan, China
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Créteil, France
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La Rochelle, France
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La Tronche, France
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Nantes, France
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Paris, France
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Bydgoszcz, Poland
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Study team
Sponsor
Alexion Pharmaceuticals, Inc.
Study ID D928EC00001
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.