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)

Inclusion Criteria: 1. 19 to 90 years of age 2. Participants with aortic disease scheduled for cardiac surgery via total circulatory arrest (TCA) 3. Body weight ≥ 30 kg 4. Participants with vital signs within the following ranges * Temperature : 35.0\~37.5°C * Blood pressure : Systolic blood pressure(SBP) 100\~160 mmHg, Diastolic blood pressure(DBP) \< 100 mmHg * Pulse : 50\~100 bpm (regardless of drug use) 5. Willing to comply with the schedule and sign the informed consent Exclusion Criteria: 1. Participants scheduled for emergent or salvage cardiac surgery 2. Use of kidney replacement therapy (KRT) or presence of acute kidney injury (AKI) 3. Participants with moderate renal impairement 4. Participants at risk of bleeding 5. Participants who underwent cardiac surgery via mid-sternotomy or thoracotomy, including major congenital heart disease 6. Participants who received cardiopulmonary resuscitation within 30 days prior to cardiac surgery 7. Recipient of a solid organ or bone marrow transplantation 8. Participants with cardiogenic shock or hemodynamics instability, or planned use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device 9. Active systemic bacterial, viral, or fungal infection 10. History of HIV 11. Positive serology test for HAV, HBV, HCV or Syphilis 12. 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 13. Uncontrolled hypertension 14. History of congenital immunodeficiency 15. Genetic disorder with severe and abnormal bilirubin metabolism 16. Participants deemed unsuitable for the study in the discretion of the investigator 17. History of malignancy 18. Planned use of any pharmacologic agent other than the IP assigned in this study for the prevention or treatment of acute kidney injury 19. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents 20. History of participation in other clinical trials within 30 days 21. Presence of a do-not-resuscitate order or life expectancy of \< 3 months 22. Female subjects of childbearing potential 23. 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 24. Poorly controlled type 2 diabetes mellitus 25. New York Heart Association (NYHA) Class IV heart failure