Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT07164833
Status:
RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of BX-001N in Preventing Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Major Adverse Kidney Events (MAKE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-09-08', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in NGAL levels', 'timeFrame': 'Baseline(Day -1) to Day 7'}, {'measure': 'Change from baseline in sCr levels', 'timeFrame': 'Baseline(Day -1) to Day 7'}, {'measure': 'Change from baseline in eGFR', 'timeFrame': 'Baseline(Day -1) to Day 30'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in CysC', 'timeFrame': 'Baseline(Day -1) to Day 7'}, {'measure': 'Change from baseline in TIMP-2', 'timeFrame': 'Baseline(Day -1) to Day 7'}, {'measure': 'Change from baseline in IGFBP7', 'timeFrame': 'Baseline(Day -1) to Day 7'}, {'measure': 'Collection of Major Adverse Renal Events [MAKE]', 'timeFrame': 'Up to Day 90'}, {'measure': 'Change from baseline in Incidence of AKI based on Kidney Disease: Improving Global Outcomes [KDIGO] criteria', 'timeFrame': 'Baseline(Day -1) to Day 7', 'description': '\\[Staging of AKI\\] Stage 1 : 1.5-1.9 times baseline or ≥0.3mg/dL increase Stage 2 : 2.0-2.9 times baseline Stage 3 : 3.0 times baseline or increase in serum creatinine to ≥4.0mg/dL or Initiation of renal replacement therapy'}, {'measure': 'Change from baseline in BUN', 'timeFrame': 'Baseline(Day -1) to Day 30'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemia Reperfusion Injury', 'Cardiac Surgery Associated - Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'This is a Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a clinical trial of BX-001N to prevent patients from Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and subsequent Major Adverse Kidney Events (MAKE) in approximately 40 participants.', 'detailedDescription': 'This study will enroll approximately 40 participants, with 16 participants randomized to Experimental Group 1, 16 participants to Experimental Group 2, and 8 participants to the Placebo Group.\n\nRandomized participants will be hospitalized from one day prior to surgery (Baseline, Day -1) through Day 7.\n\nInvestigational product (IP) (i.e., BX-001N) will be administered intravenously at a weight-based dose as follows: The test drug will be administered three times in total. Participants in the Placebo Group will receive placebo at the same time points and in the same manner.\n\nFollow-up visits will be conducted up to Day 90 at the study site for scheduled efficacy and safety assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 19 to 90 years of age\n2. Participants with aortic disease scheduled for cardiac surgery via total circulatory arrest (TCA)\n3. Body weight ≥ 30 kg\n4. Participants with vital signs within the following ranges\n\n * Temperature : 35.0\\~37.5°C\n * Blood pressure : Systolic blood pressure(SBP) 100\\~160 mmHg, Diastolic blood pressure(DBP) \\< 100 mmHg\n * Pulse : 50\\~100 bpm (regardless of drug use)\n5. Willing to comply with the schedule and sign the informed consent\n\nExclusion Criteria:\n\n1. Participants scheduled for emergent or salvage cardiac surgery\n2. Use of kidney replacement therapy (KRT) or presence of acute kidney injury (AKI)\n3. Participants with moderate renal impairement\n4. Participants at risk of bleeding\n5. Participants who underwent cardiac surgery via mid-sternotomy or thoracotomy, including major congenital heart disease\n6. Participants who received cardiopulmonary resuscitation within 30 days prior to cardiac surgery\n7. Recipient of a solid organ or bone marrow transplantation\n8. Participants with cardiogenic shock or hemodynamics instability, or planned use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device\n9. Active systemic bacterial, viral, or fungal infection\n10. History of HIV\n11. Positive serology test for HAV, HBV, HCV or Syphilis\n12. Participants with impaired liver function due to cirrhosis, or those with 2x UNR blood levels of ALP, AST, or ALT, or with total bilirubin levels outside the normal range\n13. Uncontrolled hypertension\n14. History of congenital immunodeficiency\n15. Genetic disorder with severe and abnormal bilirubin metabolism\n16. Participants deemed unsuitable for the study in the discretion of the investigator\n17. History of malignancy\n18. Planned use of any pharmacologic agent other than the IP assigned in this study for the prevention or treatment of acute kidney injury\n19. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents\n20. History of participation in other clinical trials within 30 days\n21. Presence of a do-not-resuscitate order or life expectancy of \\< 3 months\n22. Female subjects of childbearing potential\n23. Male subjects and their spouse/partner are not willing to use appropriate contraception, or if their spouse/partner is pregnant, breastfeeding or has a plan\n24. Poorly controlled type 2 diabetes mellitus\n25. New York Heart Association (NYHA) Class IV heart failure'}, 'identificationModule': {'nctId': 'NCT07164833', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of BX-001N in Preventing Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Major Adverse Kidney Events (MAKE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bilix Co.,Ltd.'}, 'officialTitle': 'Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a Clinical Trial of BX-001N to Prevent From Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE)', 'orgStudyIdInfo': {'id': 'BX-001N-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BX-001N Experimental group 1', 'description': 'Three low doses of BX-001N once a day on the scheduled date', 'interventionNames': ['Drug: BX-001N Experimental group 1']}, {'type': 'EXPERIMENTAL', 'label': 'BX-001N Experimental group 2', 'description': 'Three high doses of BX-001N once a day on the scheduled date', 'interventionNames': ['Drug: BX-001N Experimental group 2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Three low doses of placebo once a day on the scheduled date', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BX-001N Experimental group 1', 'type': 'DRUG', 'description': 'Each participant will receive BX-001N at a weight-based low dose via IV injection once daily for a total of three administrations.', 'armGroupLabels': ['BX-001N Experimental group 1']}, {'name': 'BX-001N Experimental group 2', 'type': 'DRUG', 'description': 'Each participant will receive BX-001N at a weight-based high dose via IV injection once daily at the same time during hospitalization, for a total of three administrations.', 'armGroupLabels': ['BX-001N Experimental group 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Each participant will receive Placebo at a weight-based dose via IV injection once daily at the same time during hospitalization, for a total of three administrations.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02841', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'KU Medicine HRPC', 'role': 'CONTACT', 'email': 'aarst@kumc.or.kr', 'phone': '+82-2-920-6086'}, {'name': 'Hee Jung Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seoul National University Hospital IRB', 'role': 'CONTACT', 'email': 'irb@snuh.org', 'phone': '+82-2-2072-0694'}, {'name': 'Jae Woong Choi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Severance Hospital Clinical Trial Center', 'role': 'CONTACT', 'email': 'irb@yuhs.ac', 'phone': '+82-2-2228-0430'}, {'name': 'Hyun Chel Joo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'AMC IRB', 'role': 'CONTACT', 'email': 'irb@amc.seoul.kr', 'phone': '+82-2-3010-7166'}, {'name': 'Joon Bum Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul Asan Medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '50612', 'city': 'Yangsan', 'status': 'NOT_YET_RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Pusan National University Yangsan Hospital IRB', 'role': 'CONTACT', 'email': 'pnuyhctc@pnuyh.co.kr', 'phone': '+82-55-360-3854'}, {'name': 'Chee Hoon Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}], 'centralContacts': [{'name': 'Choonmo Kang', 'role': 'CONTACT', 'email': 'choonmo.kang@bilix.com', 'phone': '+82-70-7791-5721'}, {'name': 'Soobin Son', 'role': 'CONTACT', 'email': 'Soobin.Son@bilix.com', 'phone': '+82-31-212-0961'}], 'overallOfficials': [{'name': 'Myung Lip Kim, Chief Executive Officer', 'role': 'STUDY_CHAIR', 'affiliation': 'Bilix Co.,Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bilix Co.,Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}