Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-26 @ 12:16 AM
Study NCT ID:
NCT05746559
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2023-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Greece']}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629409', 'term': 'ravulizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 736}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-02-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2023-02-16', 'studyFirstSubmitQcDate': '2023-02-16', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB)', 'timeFrame': 'Day 90 post-CPB'}], 'secondaryOutcomes': [{'measure': 'To assess the efficacy of ravulizumab in reducing risk of AKI (based on sCr) following CPB', 'timeFrame': 'Day 90 post CPB', 'description': '1. Occurrence of CSA-AKI without recovery at Day 90 post CPB\n2. Occurrence of severe CSA-AKI (KDIGO Stage 2 or 3) from randomization to Day 7 post CPB\n3. Occurrence of severe AKI (KDIGO Stage 2 or 3) from randomization to Day 30 post CPB\n4. Occurrence of KRT or death from randomization to Day 90 post CPB\n5. All-cause mortality from randomization to Day 90 post CPB\n6. Length of post-operative ICU stay'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Kidney Disease', 'CKD', 'Cardiac Disease', 'Cardiopulmonary Bypass'], 'conditions': ['Chronic Kidney Disease', 'CKD', 'Cardiac Disease', 'Cardiopulmonary Bypass']}, 'referencesModule': {'references': [{'pmid': '40448185', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant weighs ≥ 30 kg\n* Planned non-emergent sternotomy with CPB procedure for the following surgeries:\n* Multi-vessel CABG\n* Valve replacement or repair; ascending aorta surgery permitted if combined with aortic valve replacement/repair\n* Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement/repair is permitted\n* Known CKD for at least 90 days (CKD Stage 3A, 3B, or 4)\n\nExclusion Criteria:\n\n* Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the investigator.\n* Single-vessel CABG without valve surgery is planned.\n* Off-pump surgery is planned (eg, surgery without CPB).\n* Recipient of a solid organ or bone marrow transplantation.\n* Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization.\n* Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.\n* History of unexplained, recurrent infection.\n* Any use of KRT or presence of AKI within 30 days of randomization\n* 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.\n* Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics , if needed\n* History of or unresolved N meningitidis infection.'}, 'identificationModule': {'nctId': 'NCT05746559', 'acronym': 'ARTEMIS', 'briefTitle': 'ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'D928DC00001'}, 'secondaryIdInfos': [{'id': 'ALXN1210-CSA-AKI-318', 'type': 'OTHER', 'domain': 'Alexion Pharmaceuticals, Inc.'}, {'id': '2022-501802-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive a single weight-based dose of placebo via intravenous infusion, 1 to 7 days prior to surgery.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ravulizumab', 'description': 'Participants will receive a single weight-based dose of ravulizumab, via intravenous infusion, 1 to 7 days prior to surgery.', 'interventionNames': ['Drug: Ravulizumab']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive a single weight-based dose of placebo via intravenous infusion.', 'armGroupLabels': ['Placebo']}, {'name': 'Ravulizumab', 'type': 'DRUG', 'description': 'Participants will receive a single weight-based dose of ravulizumab via intravenous infusion.', 'armGroupLabels': ['Ravulizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92868', 'city': 'Orange', 'state': 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