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)

NCT07164833 | Recruiting Phase 2 DMC

• 1 other identifier: BX-001N-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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 subsequent Major Adverse Kidney Events (MAKE) in approximately 40 participants.

Conditions

Ischemia Reperfusion Injury; Cardiac Surgery Associated - Acute Kidney Injury

Outcome Measures

Primary Outcomes (3)

• Change from baseline in NGAL levels

  Baseline(Day -1) to Day 7

• Change from baseline in sCr levels

  Baseline(Day -1) to Day 7

• Change from baseline in eGFR

  Baseline(Day -1) to Day 30

Secondary Outcomes (6)

• Change from baseline in CysC

  Baseline(Day -1) to Day 7

• Change from baseline in TIMP-2

  Baseline(Day -1) to Day 7

• Change from baseline in IGFBP7

  Baseline(Day -1) to Day 7

• Collection of Major Adverse Renal Events [MAKE]

  Up to Day 90

• Change from baseline in Incidence of AKI based on Kidney Disease: Improving Global Outcomes [KDIGO] criteria

  Baseline(Day -1) to Day 7

Study Arms (3)

BX-001N Experimental group 1

EXPERIMENTAL

Three low doses of BX-001N once a day on the scheduled date

Drug: BX-001N Experimental group 1

BX-001N Experimental group 2

EXPERIMENTAL

Three high doses of BX-001N once a day on the scheduled date

Drug: BX-001N Experimental group 2

Placebo

PLACEBO COMPARATOR

Three low doses of placebo once a day on the scheduled date

Drug: Placebo

Interventions

BX-001N Experimental group 1 DRUG

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 1

BX-001N Experimental group 2 DRUG

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.

BX-001N Experimental group 2

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Bilix Co.,Ltd.: lead

Study Sites (5)

Korea University Anam Hospital

Seoul, 02841, South Korea

NOT YET RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

NOT YET RECRUITING

Seoul Asan Medical center

Seoul, 05505, South Korea

NOT YET RECRUITING

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Myung Lip Kim, Chief Executive Officer

  Bilix Co.,Ltd.

  STUDY CHAIR

Central Study Contacts

Choonmo Kang

CONTACT

+82-70-7791-5721; choonmo.kang@bilix.com

Soobin Son

CONTACT

+82-31-212-0961; Soobin.Son@bilix.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 10, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)