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Clinical Trial Details

Trial ID: L0870
Source ID: NCT05746559
Associated Drug: Placebo
Title: ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE
Acronym: ARTEMIS
Status: RECRUITING
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|CKD|Cardiac Disease|Cardiopulmonary Bypass
Interventions: DRUG: Placebo|DRUG: Ravulizumab
Outcome Measures: Primary: 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: To assess the efficacy of ravulizumab in reducing risk of AKI (based on sCr) following CPB, 1. Occurrence of CSA-AKI without recovery at Day 90 post CPB 2. Occurrence of severe CSA-AKI (KDIGO Stage 2 or 3) from randomization to Day 7 post CPB 3. Occurrence of severe AKI (KDIGO Stage 2 or 3) from randomization to Day 30 post CPB 4. Occurrence of KRT or death from randomization to Day 90 post CPB 5. All-cause mortality from randomization to Day 90 post CPB 6. Length of post-operative ICU stay, Day 90 post CPB
Sponsor/Collaborators: Sponsor: Alexion Pharmaceuticals, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 736
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-04-06
Completion Date: 2027-02-17
Results First Posted:
Last Update Posted: 2025-04-17
Locations: Research Site, Tucson, Arizona, 85719, United States|Research Site, Orange, California, 92868, United States|Research Site, San Francisco, California, 94121, United States|Research Site, San Francisco, California, 94143, United States|Research Site, Stanford, California, 94305, United States|Research Site, Aurora, Colorado, 80045, United States|Research Site, Washington, District of Columbia, 20037-2342, United States|Research Site, Gainesville, Florida, 32610, United States|Research Site, Orlando, Florida, 32804, United States|Research Site, Weston, Florida, 33331, United States|Research Site, Atlanta, Georgia, 30309, United States|Research Site, Chicago, Illinois, 60637, United States|Research Site, Fort Wayne, Indiana, 46804, United States|Research Site, Indianapolis, Indiana, 46237, United States|Research Site, Louisville, Kentucky, 40202, United States|Research Site, Boston, Massachusetts, 02115, United States|Research Site, Springfield, Massachusetts, 01107, United States|Research Site, Detroit, Michigan, 48201, United States|Research Site, Kansas City, Missouri, 64111, United States|Research Site, Saint Louis, Missouri, 63110, United States|Research Site, Lincoln, Nebraska, 68506, United States|Research Site, Haddon Heights, New Jersey, 08035, United States|Research Site, Rochester, New York, 14621, United States|Research Site, Valhalla, New York, 10595, United States|Research Site, Durham, North Carolina, 27705, United States|Research Site, Winston-Salem, North Carolina, 27157, United States|Research Site, Fargo, North Dakota, 58102, United States|Research Site, Cleveland, Ohio, 44106, United States|Research Site, Cleveland, Ohio, 44126, United States|Research Site, Columbus, Ohio, 43210, United States|Research Site, Philadelphia, Pennsylvania, 19104, United States|Research Site, Philadelphia, Pennsylvania, 19140, United States|Research Site, Philadelphia, Pennsylvania, 19141, United States|Research Site, Charleston, South Carolina, 29425, United States|Research Site, Dallas, Texas, 75390, United States|Research Site, Houston, Texas, 77030, United States|Research Site, Plano, Texas, 75093, United States|Research Site, San Antonio, Texas, 78229, United States|Research Site, Salt Lake City, Utah, 84132, United States|Research Site, Charlottesville, Virginia, 22908, United States|Research Site, Richmond, Virginia, 23298, United States|Research Site, Seattle, Washington, 98195, United States|Research Site, Tacoma, Washington, 98405, United States|Research Site, Wisconsin Rapids, Wisconsin, 54494, United States|Research Site, Buenos Aires, C1110 AAF, Argentina|Research Site, Buenos Aires, C1180AAV, Argentina|Research Site, Caba, C1428DCO, Argentina|Research Site, Ciudad Autónoma de Bs. As., C1199ABB, Argentina|Research Site, Cordoba, X5000 FAL, Argentina|Research Site, Cordoba, X5016, Argentina|Research Site, Corrientes, W3400AMZ, Argentina|Research Site, Córdoba, X5016LIG, Argentina|Research Site, San Luis, 5700, Argentina|Research Site, Santa Fé, S3000EOM, Argentina|Research Site, Adelaide, 5000, Australia|Research Site, Brisbane, 4102, Australia|Research Site, Canberra, 2605, Australia|Research Site, Heidelberg, 3081, Australia|Research Site, Monash, Australia|Research Site, Murdoch, 6150, Australia|Research Site, Southport, 4215, Australia|Research Site, Vienna, A-1090, Austria|Research Site, Belo Horizonte, 30150-221, Brazil|Research Site, Brasillia, 70658-700, Brazil|Research Site, Campinas, 13060-080, Brazil|Research Site, Fortaleza, 60430-375, Brazil|Research Site, Porto Alegre, 90620-001, Brazil|Research Site, Recife, 50070-550, Brazil|Research Site, Ribeirão Preto, 14051-140, Brazil|Research Site, Rio de Janeiro, 22270-005, Brazil|Research Site, S.J. Do Rio Preto, 15090-000, Brazil|Research Site, Salvador, 40301-155, Brazil|Research Site, Sao Paulo, 05403-000, Brazil|Research Site, São Paulo, 01323-900, Brazil|Research Site, São Paulo, 04012-180, Brazil|Research Site, Edmonton, Alberta, T6G 2B7, Canada|Research Site, Winnipeg, Manitoba, R2H 2A6, Canada|Research Site, Saint John, New Brunswick, E2L 4L4, Canada|Research Site, Hamilton, Ontario, L8L 2X2, Canada|Research Site, Kingston, Ontario, K7L 2V7, Canada|Research Site, Toronto, Ontario, M5B 1W8, Canada|Research Site, Montreal, Quebec, H2X 0C1, Canada|Research Site, Montreal, Quebec, H4J 1C5, Canada|Research Site, Montréal, Quebec, H1T 1C8, Canada|Research Site, Beijing, 100029, China|Research Site, Fuzhou, 350001, China|Research Site, Gaozhou, 525232, China|Research Site, Guangzhou, 510120, China|Research Site, Hangzhou, 310013, China|Research Site, Hangzhou, 310014, China|Research Site, Huai'an, 223300, China|Research Site, Ningbo, 315100, China|Research Site, Shanghai, 200032, China|Research Site, Shanghai, 200080, China|Research Site, Shenzhen, 518036, China|Research Site, Shenzhen, 518053, China|Research Site, Tianjin, 300050, China|Research Site, Wuhan, 430071, China|Research Site, Wuhan, CN-430022, China|Research Site, Xi'an, 710061, China|Research Site, Zhengzhou City, 450000, China|Research Site, Zhengzhou, 450002, China|Research Site, Zhengzhou, 450007, China|Research Site, Zhengzhou, 450052, China|Research Site, Zunyi, 563100, China|Research Site, Bordeaux Cedex, 33074, France|Research Site, Dijon Cedex, 21079, France|Research Site, Montpellier, 34000, France|Research Site, Toulouse Cedex 3, 31076, France|Research Site, Dresden, 01307, Germany|Research Site, Essen, 45147, Germany|Research Site, Frankfurt am Main, 60590, Germany|Research Site, Giessen, 35392, Germany|Research Site, Halle (Saale), 06120, Germany|Research Site, Heidelberg, 69120, Germany|Research Site, Jena, 07747, Germany|Research Site, Muenster, 48149, Germany|Research Site, München, 81377, Germany|Research Site, Stuttgart, 70376, Germany|Research Site, Trier, 54292, Germany|Research Site, Hong Kong, 999077, Hong Kong|Research Site, Bangalore, 560069, India|Research Site, Bangalore, 560092, India|Research Site, Delhi, 110060, India|Research Site, Gurgaon, 122001, India|Research Site, Hyderabad, 500 034, India|Research Site, Mysuru, 570004, India|Research Site, Secunderabad, 500003, India|Research Site, Haifa, 3109601, Israel|Research Site, Haifa, 34362, Israel|Research Site, Petah Tikva, 4941492, Israel|Research Site, Ramat Gan, 52621, Israel|Research Site, Bari, 70124, Italy|Research Site, Firenze, 50134, Italy|Research Site, Milano, 20121, Italy|Research Site, Milan, 20138, Italy|Research Site, Napoli, 80131, Italy|Research Site, Bunkyo-ku, 113-8431, Japan|Research Site, Chuo-ku, 104-8560, Japan|Research Site, Kamakura-shi, 247-8533, Japan|Research Site, Kawasaki-shi, 216-8511, Japan|Research Site, Minato-ku, 105-8470, Japan|Research Site, Okayama-shi, 700-0804, Japan|Research Site, Sagamihara-shi, 252-0375, Japan|Research Site, Suginami, 168-0065, Japan|Research Site, Urayasu, 279-0001, Japan|Research Site, Anyang-si, 14068, Korea, Republic of|Research Site, Bucheon-si, 14754, Korea, Republic of|Research Site, Busan, 49241, Korea, Republic of|Research Site, Daegu, 42472, Korea, Republic of|Research Site, Daegu, 42601, Korea, Republic of|Research Site, Seongnam-si, 13620, Korea, Republic of|Research Site, Seoul, 02841, Korea, Republic of|Research Site, Seoul, 03080, Korea, Republic of|Research Site, Seoul, 06351, Korea, Republic of|Research Site, Seoul, 08308, Korea, Republic of|Research Site, Seoul, 120-752, Korea, Republic of|Research Site, Groningen, 9713 GZ, Netherlands|Research Site, Maastricht, 6229 HX, Netherlands|Research Site, Rotterdam, 3015 GD, Netherlands|Research Site, Białystok, 15-276, Poland|Research Site, Bielsko-Biała, 43-316, Poland|Research Site, Chrzanów, 32-500, Poland|Research Site, Grudziądz, 86-300, Poland|Research Site, Katowice, 40-635, Poland|Research Site, Kraków, 31-202, Poland|Research Site, Poznań, 60-355, Poland|Research Site, Szczecin, 70-111, Poland|Research Site, Tychy, 43-100, Poland|Research Site, Warszawa, 02-972, Poland|Research Site, Łódź, 91-347, Poland|Research Site, Łódź, 92-213, Poland|Research Site, Coimbra, 3000-075, Portugal|Research Site, Lisboa, 1169-024, Portugal|Research Site, Lisboa, 1649-035, Portugal|Research Site, A Coruna, 15006, Spain|Research Site, Barcelona, 08036, Spain|Research Site, Barcelona, 8035, Spain|Research Site, Córdoba, 14004, Spain|Research Site, Madrid, 28040, Spain|Research Site, Madrid, 28041, Spain|Research Site, Majadahonda, 28250, Spain|Research Site, Navarra, 31190, Spain|Research Site, Santander, 39008, Spain|Research Site, Sevilla, 41071, Spain|Research Site, Valencia, 46010, Spain|Research Site, Valladolid, 47003, Spain|Research Site, Hualien City, 970473, Taiwan|Research Site, Kaohsiung, 83301, Taiwan|Research Site, New Taipei, 220, Taiwan|Research Site, Taichung, 40447, Taiwan|Research Site, Tainan City, 70403, Taiwan|Research Site, Taipei City, 11696, Taiwan|Research Site, Taipei, 10002, Taiwan|Research Site, Ankara, 06800, Turkey|Research Site, Antalya, 07100, Turkey|Research Site, Istanbul, 34093, Turkey|Research Site, Istanbul, 34303, Turkey|Research Site, Istanbul, 34349, Turkey|Research Site, Istanbul, 34668, Turkey|Research Site, Istanbul, 34846, Turkey|Research Site, Menemen/Izmir, 35665, Turkey|Research Site, Odunpazarı, 26080, Turkey|Research Site, Cambridge, CB2 0AY, United Kingdom|Research Site, Clydebank, G81 4DY, United Kingdom|Research Site, Edinburgh, EH16 4SA, United Kingdom|Research Site, London, SE1 9RT, United Kingdom|Research Site, London, SW17 0QT, United Kingdom|Research Site, London, W12 0HS, United Kingdom|Research Site, Newcastle upon Tyne, NE7 7DN, United Kingdom
URL: https://clinicaltrials.gov/show/NCT05746559

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress