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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
544
Start Date
2023-04-06
Completion Date
2026-05-07
Last Updated
2026-06-30
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 (130)
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Orange, California, United States
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San Francisco, California, United States
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Stanford, California, United States
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Chicago, Illinois, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Kansas City, 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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Fargo, North Dakota, 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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Charlottesville, Virginia, United States
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Richmond, Virginia, United States
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Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Ciudad de Buenos Aires, Argentina
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Corrientes, Argentina
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Santa Fe, Argentina
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Brisbane, Australia
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Monash, Australia
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Murdoch, Australia
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Southport, Australia
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Belo Horizonte, Brazil
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Fortaleza, Brazil
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Recife, Brazil
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Ribeirão Preto, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Edmonton, Alberta, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Shanghai, China
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Shanghai, China
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Shenzhen, China
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Tianjin, China
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Zhengzhou, China
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Zhengzhou, China
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Bordeaux, France
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Montpellier, France
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Toulouse, France
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Frankfurt am Main, Germany
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Giessen, Germany
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Halle, Germany
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Heidelberg, Germany
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Jena, Germany
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München, Germany
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Trier, Germany
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Bangalore, India
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Mysuru, India
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Secunderabad, India
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Haifa, Israel
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Haifa, Israel
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Bari, Italy
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Florence, Italy
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Naples, Italy
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Bunkyō City, Japan
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Chūōku, Japan
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Kamakura-shi, Japan
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Kawasaki-shi, Japan
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Minatoku, Japan
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Okayama, Japan
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Sagamihara-shi, Japan
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Suginami City, Japan
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Urayasu, Japan
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Groningen, Netherlands
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Maastricht, Netherlands
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Bielsko-Biala, Poland
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Chrzanów, Poland
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Lodz, Poland
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Lodz, Poland
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Seoul, South Korea
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A Coruña, Spain
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Madrid, Spain
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Navarra, Spain
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Seville, Spain
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Valladolid, Spain
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Hualien City, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Ankara, Turkey (Türkiye)
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Antalya, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Menemen/Izmir, Turkey (Türkiye)
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Odunpazari, Turkey (Türkiye)
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Cambridge, United Kingdom
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Clydebank, United Kingdom
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London, United Kingdom
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Newcastle upon Tyne, United Kingdom