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)

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.

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:

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