Status:
RECRUITING
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)
Lead Sponsor:
Bilix Co.,Ltd.
Conditions:
Ischemia Reperfusion Injury
Cardiac Surgery Associated - Acute Kidney Injury
Eligibility:
All Genders
19-90 years
Phase:
PHASE2
Brief Summary
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 subsequen...
Detailed Description
This study will enroll approximately 40 participants, with 16 participants randomized to Experimental Group 1, 16 participants to Experimental Group 2, and 8 participants to the Placebo Group. Random...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Participants scheduled for emergent or salvage cardiac surgery
- Use of kidney replacement therapy (KRT) or presence of acute kidney injury (AKI)
- Participants with moderate renal impairement
- 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
Key Trial Info
Start Date :
August 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07164833
Start Date
August 26 2025
End Date
February 1 2027
Last Update
September 10 2025
Active Locations (5)
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1
Korea University Anam Hospital
Seoul, South Korea, 02841
2
Seoul National University Hospital
Seoul, South Korea, 03080
3
Severance Hospital
Seoul, South Korea, 03722
4
Seoul Asan Medical center
Seoul, South Korea, 05505