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)

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