ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE
Launched by ALEXION PHARMACEUTICALS, INC. · Feb 16, 2023
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
The ARTEMIS clinical trial is studying whether a single dose of a medication called ravulizumab can help protect patients with chronic kidney disease (CKD) from acute kidney injury (AKI) after they undergo certain types of heart surgery. AKI can lead to serious health problems, so the trial aims to see if ravulizumab can reduce these risks in adult patients who are scheduled for non-emergency heart surgery that involves a heart-lung machine.
To participate in this study, you must be an adult weighing at least 30 kg and have been diagnosed with CKD for at least 90 days. Eligible surgeries include multi-vessel bypass surgery, valve replacement or repair, and combined procedures involving both. Participants will receive either the study medication or a placebo (a non-active treatment) and will be monitored for 90 days to see how well they do. It's important to note that there are certain health conditions and recent medical treatments that may exclude someone from participating, so it's best to discuss your specific situation with your healthcare provider.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participant weighs ≥ 30 kg
- * 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:
- • Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the investigator.
- • 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.
About Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc. is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for patients with rare and complex diseases. With a strong focus on addressing unmet medical needs, Alexion leverages advanced science and technology to create transformative treatments that improve the quality of life for patients suffering from conditions such as complement-mediated disorders, neurology, hematology, and metabolic diseases. Committed to patient-centric approaches, Alexion collaborates with healthcare professionals, patients, and advocacy groups to drive clinical research and foster advancements in rare disease treatment.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Houston, Texas, United States
Charlottesville, Virginia, United States
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Rochester, New York, United States
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Córdoba, , Spain
Philadelphia, Pennsylvania, United States
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Vienna, , Austria
Kingston, Ontario, Canada
München, , Germany
Athens, , Greece
Bari, , Italy
Rotterdam, , Netherlands
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Durham, North Carolina, United States
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Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
Heidelberg, , Germany
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Lisboa, , Portugal
Stanford, California, United States
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Thessaloniki, , Greece
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Ramat Gan, , Israel
Szczecin, , Poland
Giessen, , Germany
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Essen, , Germany
Milano, , Italy
Weston, Florida, United States
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Edmonton, Alberta, Canada
Ciudad Autónoma De Bs. As., , Argentina
San Luis, , Argentina
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Bangalore, , India
Petah Tikva, , Israel
Okayama Shi, , Japan
Bielsko Biała, , Poland
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Antalya, , Turkey
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Southport, , Australia
Tianjin, , China
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Sagamihara Shi, , Japan
Taipei City, , Taiwan
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Katowice, , Poland
New Taipei, , Taiwan
łódź, , Poland
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Porto Alegre, , Brazil
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Anyang Si, , Korea, Republic Of
Wuhan, , China
Alexandroupolis, , Greece
Hangzhou, , China
Belo Horizonte, , Brazil
Guangzhou, , China
Hangzhou, , China
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Gurgaon, , India
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Zhengzhou City, , China
Istanbul, , Turkey
Campinas, , Brazil
Clydebank, , United Kingdom
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Kamakura Shi, , Japan
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Zunyi, , China
Recife, , Brazil
A Coruna, , Spain
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Secunderabad, , India
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Ningbo, , China
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Huai'an, , China
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S.J. Do Rio Preto, , Brazil
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Suginami, , Japan
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Taipei City, , Taiwan
Saint John, New Brunswick, Canada
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Salvador, , Brazil
Gaozhou, , China
Delhi, , India
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Odunpazarı, , Turkey
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Bordeaux Cedex, , France
Brasillia, , Brazil
Menemen/Izmir, , Turkey
Tianjin, , China
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Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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