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 6. Participants with moderate renal impairement 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 at risk of bleeding 4. Participants who underwent cardiac surgery via mid-sternotomy or thoracotomy, including major congenital heart disease 5. Participants who received cardiopulmonary resuscitation within 30 days prior to cardiac surgery 6. Recipient of a solid organ or bone marrow transplantation 7. Participants with cardiogenic shock or hemodynamics instability, or planned use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device 8. Active systemic bacterial, viral, or fungal infection 9. History of HIV 10. Positive serology test for HAV, HBV, HCV or Syphilis 11. 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 12. Uncontrolled hypertension 13. History of congenital immunodeficiency 14. Genetic disorder with severe and abnormal bilirubin metabolism 15. Participants deemed unsuitable for the study in the discretion of the investigator 16. History of malignancy 17. Planned use of any pharmacologic agent other than the IP assigned in this study for the prevention or treatment of acute kidney injury 18. History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents 19. History of participation in other clinical trials within 30 days 20. Presence of a do-not-resuscitate order or life expectancy of \< 3 months 21. Female subjects of childbearing potential 22. 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 23. Poorly controlled type 2 diabetes mellitus 24. New York Heart Association (NYHA) Class IV heart failure