Actively 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)
Led by Bilix Co.,Ltd. · Updated on 2025-09-10
40
Participants Needed
5
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 40 participants.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 19 and 90 years
- Scheduled for cardiac surgery via total circulatory arrest (TCA) due to aortic disease
- Body weight of at least 30 kg
- Vital signs within these ranges: temperature 35.0 to 37.5°C; systolic blood pressure 100 to 160 mmHg; diastolic blood pressure below 100 mmHg; pulse 50 to 100 bpm
- Willingness to comply with the study schedule and sign informed consent
You will not qualify if you...
- Scheduled for emergency or salvage cardiac surgery
- Use of kidney replacement therapy or presence of acute kidney injury
- Moderate renal impairment
- Risk of bleeding
- Previous cardiac surgery via mid-sternotomy or thoracotomy, including major congenital heart disease
- Cardiopulmonary resuscitation within 30 days before cardiac surgery
- Recipient of solid organ or bone marrow transplant
- Cardiogenic shock, hemodynamic 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 for hepatitis A, B, or C virus, or syphilis
- Impaired liver function due to cirrhosis, or abnormal liver enzyme levels
- Uncontrolled hypertension
- History of congenital immunodeficiency
- Genetic disorder with severe abnormal bilirubin metabolism
- Investigator judgment deeming participant unsuitable
- History of malignancy
- Planned use of other pharmacologic agents for prevention or treatment of acute kidney injury
- History of severe allergic or anaphylactic reactions to the study drug or its components
- Participation in other clinical trials within 30 days
- Presence of do-not-resuscitate order or life expectancy less than 3 months
- Female subjects of childbearing potential
- Male subjects and partners not willing to use contraception, or partners pregnant, breastfeeding, or planning pregnancy
- Poorly controlled type 2 diabetes mellitus
- New York Heart Association Class IV heart failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Korea University Anam Hospital
Seoul, South Korea, 02841
Not Yet Recruiting
2
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
3
Severance Hospital
Seoul, South Korea, 03722
Not Yet Recruiting
4
Seoul Asan Medical center
Seoul, South Korea, 05505
Not Yet Recruiting
5
Pusan National University Yangsan Hospital
Yangsan, South Korea, 50612
Not Yet Recruiting
Research Team
C
Choonmo Kang
CONTACT
S
Soobin Son
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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