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)

This study will enroll approximately 50 participants, with 16 participants randomized to Experimental Group 1 and 4 participants to the Placebo Group 1, 15 participants to Experimental Group 2 and 15 participants to the Placebo Group 2.

Randomized participants will be hospitalized from one day prior to surgery (Baseline, Day -1) through Day 7.

Investigational 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.

Follow-up visits will be conducted up to Day 90 at the study site for scheduled efficacy and safety assessments.

Inclusion criteria

• 19 to 90 years of age
• Participants with aortic disease scheduled for cardiac surgery via total circulatory arrest (TCA)
• Body weight ≥ 30 kg
• 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)
• Willing to comply with the schedule and sign the informed consent
• Participants with moderate renal impairement

Exclusion criteria

• Participants scheduled for emergent or salvage cardiac surgery
• Use of kidney replacement therapy (KRT) or presence of acute kidney injury (AKI)
• Participants at risk of bleeding
• Participants who underwent cardiac surgery via mid-sternotomy or thoracotomy, including major congenital heart disease
• Participants who received cardiopulmonary resuscitation within 30 days prior to cardiac surgery
• Recipient of a solid organ or bone marrow transplantation
• Participants with cardiogenic shock or hemodynamics instability, or planned use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device
• Active systemic bacterial, viral, or fungal infection
• History of HIV
• Positive serology test for HAV, HBV, HCV or Syphilis
• 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
• Uncontrolled hypertension
• History of congenital immunodeficiency
• Genetic disorder with severe and abnormal bilirubin metabolism
• Participants deemed unsuitable for the study in the discretion of the investigator
• History of malignancy
• Planned use of any pharmacologic agent other than the IP assigned in this study for the prevention or treatment of acute kidney injury
• History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents
• History of participation in other clinical trials within 30 days
• Presence of a do-not-resuscitate order or life expectancy of < 3 months
• Female subjects of childbearing potential
• 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
• Poorly controlled type 2 diabetes mellitus
• New York Heart Association (NYHA) Class IV heart failure