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)
NCT ID: NCT07164833
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2025-08-26
2027-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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BX-001N Experimental group 1
Three low doses of BX-001N once a day on the scheduled date
BX-001N Experimental group 1
Each participant will receive BX-001N at a weight-based low dose via IV injection once daily for a total of three administrations.
BX-001N Experimental group 2
Three high doses of BX-001N once a day on the scheduled date
BX-001N Experimental group 2
Each participant will receive BX-001N at a weight-based high dose via IV injection once daily at the same time during hospitalization, for a total of three administrations.
Placebo
Three low doses of placebo once a day on the scheduled date
Placebo
Each participant will receive Placebo at a weight-based dose via IV injection once daily at the same time during hospitalization, for a total of three administrations.
Interventions
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BX-001N Experimental group 1
Each participant will receive BX-001N at a weight-based low dose via IV injection once daily for a total of three administrations.
BX-001N Experimental group 2
Each participant will receive BX-001N at a weight-based high dose via IV injection once daily at the same time during hospitalization, for a total of three administrations.
Placebo
Each participant will receive Placebo at a weight-based dose via IV injection once daily at the same time during hospitalization, for a total of three administrations.
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
90 Years
ALL
No
Sponsors
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Bilix Co.,Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Myung Lip Kim, Chief Executive Officer
Role: STUDY_CHAIR
Bilix Co.,Ltd.
Locations
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Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Seoul Asan Medical center
Seoul, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BX-001N-002
Identifier Type: -
Identifier Source: org_study_id
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