ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE

NCT05746559 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: D928DC00001ALXN1210-CSA-AKI-3182022-501802-36
• Study Type: interventional
• Target: 736
• Locations: 20 countries
• Sites: 157

Brief 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.

Conditions

Chronic Kidney Disease; CKD; Cardiac Disease; Cardiopulmonary Bypass

Keywords

Chronic Kidney Disease; CKD; Cardiac Disease; Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB)

  Day 90 post-CPB

Secondary Outcomes (1)

• To assess the efficacy of ravulizumab in reducing risk of AKI (based on sCr) following CPB

  Day 90 post CPB

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will receive a single weight-based dose of placebo via intravenous infusion, 1 to 7 days prior to surgery.

Drug: Placebo

Ravulizumab

EXPERIMENTAL

Participants will receive a single weight-based dose of ravulizumab, via intravenous infusion, 1 to 7 days prior to surgery.

Drug: Ravulizumab

Interventions

Placebo DRUG

Participants will receive a single weight-based dose of placebo via intravenous infusion.

Placebo

Ravulizumab DRUG

Participants will receive a single weight-based dose of ravulizumab via intravenous infusion.

Ravulizumab

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Known CKD for at least 90 days (CKD Stage 3A, 3B, or 4)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (162)

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Tucson, Arizona, 85719, United States

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Orange, California, 92868, United States

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San Francisco, California, 94121, United States

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San Francisco, California, 94143, United States

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Stanford, California, 94305, United States

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Aurora, Colorado, 80045, United States

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Weston, Florida, 33331, United States

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Atlanta, Georgia, 30309, United States

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Chicago, Illinois, 60637, United States

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Indianapolis, Indiana, 46237, United States

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Boston, Massachusetts, 02115, United States

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Springfield, Massachusetts, 01107, United States

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Detroit, Michigan, 48201, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63110, United States

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Rochester, New York, 14621, United States

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Valhalla, New York, 10595, United States

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Winston-Salem, North Carolina, 27157, United States

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Fargo, North Dakota, 58102, United States

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Cleveland, Ohio, 44126, United States

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Columbus, Ohio, 43210, United States

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Philadelphia, Pennsylvania, 19140, United States

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Charleston, South Carolina, 29425, United States

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Dallas, Texas, 75390, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84132, United States

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Charlottesville, Virginia, 22908, United States

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Richmond, Virginia, 23298, United States

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Seattle, Washington, 98195, United States

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Buenos Aires, C1180AAV, Argentina

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Ciudad de Buenos Aires, C1199ABB, Argentina

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Ciudad de Buenos Aires, C1428, Argentina

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Corrientes, W3400AMZ, Argentina

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Santa Fe, S3000EOM, Argentina

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Adelaide, 5000, Australia

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Brisbane, 4102, Australia

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Monash, Australia

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Murdoch, 6150, Australia

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Southport, 4215, Australia

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Vienna, A-1090, Austria

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Belo Horizonte, 30150-221, Brazil

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Brasília, 70658-700, Brazil

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Fortaleza, 60430-375, Brazil

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Recife, 50070-550, Brazil

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Ribeirão Preto, 14051-140, Brazil

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Rio de Janeiro, 22270-005, Brazil

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Salvador, 40301-155, Brazil

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São José do Rio Preto, 15090-000, Brazil

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São Paulo, 01323-900, Brazil

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São Paulo, 04012-180, Brazil

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São Paulo, 05403-000, Brazil

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Edmonton, Alberta, T6G 2B7, Canada

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Winnipeg, Manitoba, R2H 2A6, Canada

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Saint John, New Brunswick, E2L 4L4, Canada

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Hamilton, Ontario, L8L 2X2, Canada

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Kingston, Ontario, K7L 2V7, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Montreal, Quebec, H1T 1C8, Canada

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Montreal, Quebec, H2X 0C1, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Beijing, 100029, China

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Huai'an, 223300, China

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Shanghai, 200032, China

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Shanghai, 200080, China

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Shenzhen, 518036, China

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Shenzhen, 518053, China

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Tianjin, 300050, China

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Wuhan, CN-430022, China

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Xi'an, 710061, China

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Zhengzhou, 450000, China

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Zhengzhou, 450002, China

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Zhengzhou, 450007, China

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Zhengzhou, 450052, China

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Bordeaux, 33074, France

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Dijon, 21079, France

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Montpellier, 34000, France

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Toulouse, 31076, France

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Essen, 45147, Germany

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Frankfurt am Main, 60590, Germany

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Giessen, 35392, Germany

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Halle, 06120, Germany

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Heidelberg, 69120, Germany

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Jena, 07747, Germany

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München, 81377, Germany

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Stuttgart, 70376, Germany

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Trier, 54292, Germany

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Hong Kong, 999077, Hong Kong

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Bangalore, 560069, India

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Bangalore, 560092, India

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Delhi, 110025, India

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Delhi, 110060, India

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Gūrgaon, 122001, India

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Hyderabad, 500 034, India

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Mysuru, 570004, India

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Secunderabad, 500003, India

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Haifa, 3109601, Israel

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Haifa, 34362, Israel

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Bari, 70124, Italy

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Florence, 50134, Italy

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Milan, 20138, Italy

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Naples, 80131, Italy

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Bunkyō City, 113-8431, Japan

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Chūōku, 104-8560, Japan

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Kamakura-shi, 247-8533, Japan

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Kawasaki-shi, 216-8511, Japan

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Minatoku, 105-8470, Japan

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Okayama, 700-0804, Japan

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Sagamihara-shi, 252-0375, Japan

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Suginami City, 168-0065, Japan

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Urayasu, 279-0001, Japan

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Groningen, 9713 GZ, Netherlands

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Maastricht, 6229 HX, Netherlands

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Bialystok, 15-276, Poland

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Bielsko-Biala, 43-316, Poland

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Chrzanów, 32-500, Poland

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Krakow, 31-202, Poland

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Lodz, 91-347, Poland

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Lodz, 92-213, Poland

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Poznan, 60-355, Poland

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Szczecin, 70-111, Poland

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Tychy, 43-100, Poland

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Anyang-si, 14068, South Korea

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Bucheon-si, 14754, South Korea

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Busan, 49241, South Korea

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Daegu, 42601, South Korea

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Seongnam-si, 13620, South Korea

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Seoul, 02841, South Korea

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Seoul, 03080, South Korea

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Seoul, 06351, South Korea

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Seoul, 08308, South Korea

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Seoul, 120-752, South Korea

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A Coruña, 15006, Spain

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Barcelona, 08036, Spain

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Barcelona, 8035, Spain

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Córdoba, 14004, Spain

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Madrid, 28040, Spain

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Madrid, 28041, Spain

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Majadahonda, 28250, Spain

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Navarra, 31190, Spain

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Seville, 41071, Spain

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Valencia, 46010, Spain

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Valladolid, 47003, Spain

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Hualien City, 970473, Taiwan

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Kaohsiung City, 83301, Taiwan

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New Taipei City, 220, Taiwan

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Taichung, 40447, Taiwan

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Tainan, 70403, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 11696, Taiwan

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Ankara, 06800, Turkey (Türkiye)

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Antalya, 07100, Turkey (Türkiye)

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Istanbul, 34303, Turkey (Türkiye)

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Istanbul, 34846, Turkey (Türkiye)

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Menemen/Izmir, 35665, Turkey (Türkiye)

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Odunpazari, 26080, Turkey (Türkiye)

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Cambridge, CB2 0AY, United Kingdom

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Clydebank, G81 4DY, United Kingdom

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Edinburgh, EH16 4SA, United Kingdom

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London, SE1 9RT, United Kingdom

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London, SW17 0QT, United Kingdom

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London, W12 0HS, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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Related Publications (1)

• 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.

  PMID: 40448185 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Heart Diseases

Interventions

ravulizumab

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: April 6, 2023
• Primary Completion (Estimated): May 18, 2026
• Study Completion (Estimated): February 17, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

KR (10); TW (7); PL (9); AU (1); FR (4); IN (8); ES (11); IT (4); NL (2); BR (11); TU (6); GB (7); IL (2); CA (9); DE (9); CN (13); AR (5); JP (9); US (29); HK (1)