[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605616":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":44,"centralContacts":48,"locations":58,"responsibleParty":180,"collaborators":35,"id":182,"slug":183,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":35,"eligibilityCriteria":188,"healthyVolunteers":184,"sex":189,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":35,"studyType":195,"phases":196,"briefSummary":198,"conditions":199,"keywords":35,"overallStatus":97,"whyStopped":35,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},{"fullName":5,"class":6},"Bilix Co.,Ltd.","INDUSTRY",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"BX-001N Experimental group 1","EXPERIMENTAL","Three low doses of BX-001N once a day on the scheduled date",[13],"Drug: BX-001N Experimental group 1",{"label":15,"type":10,"description":16,"interventionNames":17},"BX-001N Experimental group 2","Three high doses of BX-001N once a day on the scheduled date",[18],"Drug: BX-001N Experimental group 2",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo group 1","PLACEBO_COMPARATOR","Three low doses of placebo once a day on the scheduled date",[24],"Drug: Placebo group 1",{"label":26,"type":21,"description":27,"interventionNames":28},"Placebo group 2","Three high doses of placebo once a day on the scheduled date",[29],"Drug: Placebo group 2",[31,36,39,42],{"type":32,"name":9,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Each participant will receive BX-001N at a weight-based low dose via IV injection once daily for a total of three administrations.",[9],null,{"type":32,"name":15,"description":37,"armGroupLabels":38,"otherNames":35},"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.",[15],{"type":32,"name":20,"description":40,"armGroupLabels":41,"otherNames":35},"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.",[20],{"type":32,"name":26,"description":40,"armGroupLabels":43,"otherNames":35},[26],[45],{"name":46,"affiliation":5,"role":47},"Myung Lip Kim, Chief Executive Officer","STUDY_CHAIR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":35,"email":53},"Choonmo Kang","CONTACT","+82-70-7791-5721","choonmo.kang@bilix.com",{"name":55,"role":51,"phone":56,"phoneExt":35,"email":57},"Soobin Son","+82-31-212-0961","Soobin.Son@bilix.com",[59,79,95,112,125,138,151,164],{"facility":60,"status":61,"city":62,"state":35,"zip":63,"country":64,"countryCode":35,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Keimyung University Dongsan Medical Center","NOT_YET_RECRUITING","Daegu","42601","South Korea",{"type":66,"coordinates":67},"Point",[68,69],128.59111,35.87028,{"lat":69,"lon":68},[72,76],{"name":73,"role":51,"phone":74,"phoneExt":35,"email":75},"Keimyung University Dongsan Medical Center IRB","+82-53-258-6694","irbdsmc@naver.com",{"name":77,"role":78,"phone":35,"phoneExt":35,"email":35},"Yun Seok Kim, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":80,"status":61,"city":81,"state":35,"zip":82,"country":64,"countryCode":35,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Seoul National University Bundang Hospital","Seongnam","13620",{"type":66,"coordinates":84},[85,86],127.7548,36.4052,{"lat":86,"lon":85},[89,93],{"name":90,"role":51,"phone":91,"phoneExt":35,"email":92},"Seoul National University Bundang Hospital IRB","+82-31-787-8801","snubhirb@gmail.com",{"name":94,"role":78,"phone":35,"phoneExt":35,"email":35},"Jae Hang Lee, MD, 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MD",{"type":181,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100605616","phase-2-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-100605616",false,"NCT07164833","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)","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)","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) \\\u003C 100 mmHg\n   * Pulse : 50\\~100 bpm (regardless of drug use)\n5. Willing to comply with the schedule and sign the informed consent\n6. Participants with moderate renal impairement\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 at risk of bleeding\n4. Participants who underwent cardiac surgery via mid-sternotomy or thoracotomy, including major congenital heart disease\n5. Participants who received cardiopulmonary resuscitation within 30 days prior to cardiac surgery\n6. Recipient of a solid organ or bone marrow transplantation\n7. Participants with cardiogenic shock or hemodynamics instability, or planned use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device\n8. Active systemic bacterial, viral, or fungal infection\n9. History of HIV\n10. Positive serology test for HAV, HBV, HCV or Syphilis\n11. 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\n12. Uncontrolled hypertension\n13. History of congenital immunodeficiency\n14. Genetic disorder with severe and abnormal bilirubin metabolism\n15. Participants deemed unsuitable for the study in the discretion of the investigator\n16. History of malignancy\n17. Planned use of any pharmacologic agent other than the IP assigned in this study for the prevention or treatment of acute kidney injury\n18. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents\n19. History of participation in other clinical trials within 30 days\n20. Presence of a do-not-resuscitate order or life expectancy of \\\u003C 3 months\n21. Female subjects of childbearing potential\n22. Male subjects and their spouse\u002Fpartner are not willing to use appropriate contraception, or if their spouse\u002Fpartner is pregnant, breastfeeding or has a plan\n23. Poorly controlled type 2 diabetes mellitus\n24. New York Heart Association (NYHA) Class IV heart failure","ALL","19 Years","90 Years",{"count":193,"type":194},50,"ESTIMATED","INTERVENTIONAL",[197],"PHASE2","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 50 participants.",[200,201],"Ischemia Reperfusion Injury","Cardiac Surgery Associated - Acute Kidney Injury","2026-06-28",{"date":204,"type":205},"2026-07-01","ACTUAL",{"date":207,"type":205},"2025-08-26",{"date":209,"type":194},"2028-04",{"name":5,"class":6},8]