ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE
NCT ID: NCT05746559
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
736 participants
INTERVENTIONAL
2023-04-06
2027-02-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants will receive a single weight-based dose of placebo via intravenous infusion, 1 to 7 days prior to surgery.
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, 1 to 7 days prior to surgery.
Ravulizumab
Participants will receive a single weight-based dose of ravulizumab via intravenous infusion.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Planned non-emergent sternotomy with CPB procedure for the following surgeries:
* Multi-vessel CABG
* Valve replacement or repair; ascending aorta surgery permitted if combined with aortic valve replacement/repair
* Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement/repair is permitted
* Known CKD for at least 90 days (CKD Stage 3A, 3B, or 4)
Exclusion Criteria
* Single-vessel CABG without valve surgery is planned.
* Off-pump surgery is planned (eg, surgery without CPB).
* Recipient of a solid organ or bone marrow transplantation.
* Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization.
* Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
* History of unexplained, recurrent infection.
* Any use of KRT or presence of AKI within 30 days of randomization
* Use of any complement inhibitors, or plasmapheresis or plasma exchange within the year prior to Screening, or planned use during the course of the study.
* Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics , if needed
* History of or unresolved N meningitidis infection.
18 Years
90 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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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Ciudad de Buenos Aires, , Argentina
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Corrientes, , Argentina
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Santa Fe, , Argentina
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Adelaide, , Australia
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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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Vienna, , Austria
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Belo Horizonte, , Brazil
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Brasília, , 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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Winnipeg, Manitoba, Canada
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Saint John, New Brunswick, 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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Montreal, Quebec, Canada
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Beijing, , China
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Huai'an, , China
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Shanghai, , China
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Shanghai, , China
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Shenzhen, , China
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Shenzhen, , China
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Tianjin, , China
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Wuhan, , 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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Zhengzhou, , China
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Bordeaux, , France
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Dijon, , France
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Montpellier, , France
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Toulouse, , France
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Essen, , Germany
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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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Stuttgart, , Germany
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Trier, , Germany
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Hong Kong, , Hong Kong
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Bangalore, , India
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Bangalore, , India
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Delhi, , India
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Delhi, , India
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Gurgaon, , India
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Hyderabad, , 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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Milan, , Italy
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Napoli, , 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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Bialystok, , Poland
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Bielsko-Biala, , Poland
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Chrzanów, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Poznan, , Poland
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Szczecin, , Poland
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Tychy, , Poland
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Warsaw, , Poland
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Coimbra, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Anyang-si, , South Korea
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Bucheon-si, , South Korea
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Busan, , South Korea
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Daegu, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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A Coruña, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Navarra, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valladolid, , Spain
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Hualien City, , Taiwan
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Tainan, , 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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Edinburgh, , 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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Newcastle upon Tyne, , United Kingdom
Countries
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References
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Ostermann M, Corteville DC, Doi K, Koyner JL, Lamy A, Li G, Solinsky CM, Winterberg PD, Smith WT, Mehta RL, Murray PT, Shaw AD, Zarbock A, Engelman DT. A phase 3 study of ravulizumab to protect patients with chronic kidney disease from cardiac surgery-associated acute kidney injury and major adverse kidney events (ARTEMIS). Trials. 2025 May 30;26(1):181. doi: 10.1186/s13063-025-08895-7.
Other Identifiers
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ALXN1210-CSA-AKI-318
Identifier Type: OTHER
Identifier Source: secondary_id
2022-501802-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D928DC00001
Identifier Type: -
Identifier Source: org_study_id