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)

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Ischemia Reperfusion Injury, Cardiac Surgery Associated - Acute Kidney Injury

In brief

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 50 participants.

Key facts

Study ID

NCT07164833

Run by

Bilix Co.,Ltd.

People needed

50

Starts

2025-08-26

Expected to finish

2028-04-01

Last updated by the study team

2026-07-01

Who can join

Age: 19 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Participants with moderate renal impairement

You may not qualify if…

• Participants scheduled for emergent or salvage cardiac surgery
• Use of kidney replacement therapy (KRT) or presence of acute kidney injury (AKI)
• 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

Where it is running

• Pusan National University Yangsan Hospital — Yangsan, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Severance Hospital — Seoul, South Korea (enrolling)
• Seoul Asan Medical center — Seoul, South Korea (enrolling)
• Korea University Anam Hospital — Seoul, South Korea (enrolling)
• Seoul National University Bundang Hospital — Seongnam, South Korea
• Samsung Medical Center — Seoul, South Korea
• Keimyung University Dongsan Medical Center — Daegu, South Korea

Full record on ClinicalTrials.gov

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