BX-001N to prevent kidney injury after cardiac surgery with total circulatory arrest

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 study will see if BX-001N can prevent acute kidney injury and later major kidney problems in adults undergoing cardiac surgery with total circulatory arrest.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 19 Years to 90 Years
• Sex: All
• Sponsor: Bilix Co.,Ltd. (Industry-sponsored)
• Locations: 5 sites (Seoul and 4 other locations)
• Trial ID: NCT07164833 on ClinicalTrials.gov

What this trial studies

This randomized, single-blind, placebo-controlled Phase 2a trial will enroll about 40 adults undergoing aortic cardiac surgery with total circulatory arrest and randomize them to two different doses of BX-001N or placebo. The drug is given intravenously at weight-based doses three times, with participants hospitalized from one day before surgery through day 7 and followed for safety and efficacy through day 90. The main aims are to prevent cardiac surgery-associated acute kidney injury (CSA-AKI) and subsequent major adverse kidney events (MAKE) while monitoring safety and laboratory measures of kidney function. Efficacy and adverse events will be tracked through in-hospital assessments and scheduled outpatient follow-up visits.

Who should consider this trial

Good fit: Adults 19–90 years old scheduled for aortic surgery requiring total circulatory arrest, weighing at least 30 kg, with stable vital signs and ability to remain hospitalized through the perioperative period are the intended participants.

Not a fit: Patients who already have acute kidney injury, are receiving kidney replacement therapy, have moderate renal impairment, are at high bleeding risk, require emergency surgery, or undergo alternative surgical approaches are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If effective, BX-001N could lower the risk of acute kidney injury and downstream serious kidney events after high-risk cardiac surgery.

How similar studies have performed: Renoprotective approaches in cardiac surgery have produced mixed results, and BX-001N appears to be a novel agent with limited prior human efficacy data.

Eligibility criteria

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

Where this trial is running

Seoul and 4 other locations

• Korea University Anam Hospital — Seoul, South Korea (Not_yet_recruiting)
• Seoul National University Hospital — Seoul, South Korea (Recruiting)
• Severance Hospital — Seoul, South Korea (Not_yet_recruiting)
• Seoul Asan Medical center — Seoul, South Korea (Not_yet_recruiting)
• Pusan National University Yangsan Hospital — Yangsan, South Korea (Not_yet_recruiting)

Study contacts

• Study coordinator: Choonmo Kang

Conditions Ischemia Reperfusion Injury; Cardiac Surgery Associated - Acute Kidney Injury