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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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

Where it's running

• Korea University Anam Hospital
  Seoul, South Korea Recruiting
• Seoul National University Hospital
  Seoul, South Korea Recruiting
• Severance Hospital
  Seoul, South Korea Recruiting
• Seoul Asan Medical center
  Seoul, South Korea Recruiting
• Pusan National University Yangsan Hospital
  Yangsan, South Korea Recruiting
• Keimyung University Dongsan Medical Center
  Daegu, South Korea Not yet recruiting

Study contacts

• Study coordinator: Choonmo Kang
• Email: choonmo.kang@bilix.com
• Phone: +82-70-7791-5721

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.