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ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE
Sponsor: Alexion Pharmaceuticals, Inc.
Summary
The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.
Official title: ARTEMIS: RAvulizumab to PRotect PaTients With Chronic Kidney DisEase (CKD) froM Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE): A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
736
Start Date
2023-04-06
Completion Date
2027-02-17
Last Updated
2026-04-07
Healthy Volunteers
No
Interventions
Placebo
Participants will receive a single weight-based dose of placebo via intravenous infusion.
Ravulizumab
Participants will receive a single weight-based dose of ravulizumab via intravenous infusion.
Locations (163)
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Tucson, Arizona, United States
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Orange, California, United States
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San Francisco, California, United States
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San Francisco, California, United States
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Stanford, California, United States
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Aurora, Colorado, United States
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Weston, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Rochester, New York, United States
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Valhalla, New York, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, 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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Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Corrientes, Argentina
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Adelaide, Australia
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Murdoch, Australia
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Recife, Brazil
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Ribeirão Preto, Brazil
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Montreal, Quebec, Canada
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Tianjin, China
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Xi'an, China
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Zhengzhou, China
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Zhengzhou, China
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Zhengzhou, China
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Halle, Germany
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Szczecin, Poland
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Tychy, Poland
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Anyang-si, South Korea
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Daegu, South Korea
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Seongnam-si, South Korea
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A Coruña, Spain
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Seville, Spain
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Hualien City, Taiwan
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Odunpazari, Turkey (Türkiye)
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Cambridge, United Kingdom
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London, United Kingdom
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Newcastle upon Tyne, United Kingdom