Actively Recruiting
Randomized, Single-blind, Multi-center, Placebo-controlled Phase 2a Trial of BX-001N to Prevent Cardiac Surgery-Associated Acute Kidney Injury and Major Adverse Kidney Events
Led by Bilix Co.,Ltd. · Updated on 2025-09-10
40
Participants Needed
5
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized, single-blind, multi-center, placebo-controlled Phase 2a trial to study BX-001N in preventing acute kidney injury related to cardiac surgery and subsequent major adverse kidney events. The study aims to evaluate the efficacy and safety of BX-001N in approximately 40 adult participants undergoing cardiac surgery involving total circulatory arrest. Participants will be randomly assigned to one of three groups: two experimental groups receiving either low or high doses of BX-001N intravenously once daily for three days, and a placebo group receiving matching placebo injections on the same schedule. Hospitalization occurs from one day before surgery through Day 7, with the investigational product administered during this period. Participants will have follow-up visits up to Day 90 to assess safety and efficacy. Assessments include monitoring kidney injury biomarkers such as NGAL, serum creatinine, eGFR, and other related markers from baseline through specified days. Researchers will also track major adverse renal events and kidney function changes. Safety and treatment adherence will be closely monitored throughout the study.
CONDITIONS
Brief 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 involving total circulatory arrest due to aortic disease
- Body weight of at least 30 kilograms
- Vital signs within specified ranges: temperature 35.0 to 37.56C, systolic blood pressure 100 to 160 mmHg, diastolic blood pressure less than 100 mmHg, pulse 50 to 100 bpm
- Willingness to follow study schedule and provide informed consent
You will not qualify if you...
- Scheduled for emergency or salvage cardiac surgery
- Currently using kidney replacement therapy or having acute kidney injury
- Moderate kidney impairment
- At risk of bleeding
- Previous cardiac surgery via mid-sternotomy or thoracotomy, including major congenital heart disease
- Cardiopulmonary resuscitation within 30 days before surgery
- Recipient of solid organ or bone marrow transplant
- Cardiogenic shock, unstable hemodynamics, or planned use of advanced cardiac support devices
- Active systemic infections
- History of HIV or positive serology for hepatitis A, B, C, or syphilis
- Impaired liver function or abnormal liver enzyme levels
- Uncontrolled high blood pressure
- History of congenital immunodeficiency or severe bilirubin metabolism disorder
- History of cancer
- Use of other drugs to prevent or treat acute kidney injury
- Severe allergic reactions or sensitivity to the study drug
- Participation in another clinical trial within 30 days
- Do-not-resuscitate order or life expectancy under 3 months
- Female participants of childbearing potential
- Male participants or partners unwilling to use contraception or with pregnant/breastfeeding partners
- Poorly controlled type 2 diabetes
- Severe heart failure classified as NYHA Class IV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From Day -1 to Day 7
Participants receive three intravenous doses of BX-001N or placebo once daily during hospitalization starting the day before cardiac surgery.
Hospitalization from one day prior to surgery through Day 7
Duration - Up to 90 days after treatment
Participants return for scheduled efficacy and safety assessments up to Day 90 after treatment.
Multiple visits up to Day 90 at the study site
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
S
Soobin Son
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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