NCT07164833

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)

Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a Clinical Trial of BX-001N to Prevent From Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Bilix Co.,Ltd. · Industry
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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. Randomized participants will be hospitalized from one day prior to surgery (Baseline, Day -1) through Day 7. Investigational product (IP) (i.e., BX-001N) will be administered intravenously at a weight-based dose as follows: The test drug will be administered three times in total. Participants in the Placebo Group will receive placebo at the same time points and in the same manner. Follow-up visits will be conducted up to Day 90 at the study site for scheduled efficacy and safety assessments.

Conditions

• Ischemia Reperfusion Injury
• Cardiac Surgery Associated - Acute Kidney Injury

Interventions

Type	Name	Description
DRUG	BX-001N Experimental group 1	Each participant will receive BX-001N at a weight-based low dose via IV injection once daily for a total of three administrations.
DRUG	BX-001N Experimental group 2	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.
DRUG	Placebo	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.

Timeline

• Start date: 2025-08-26
• Primary completion: 2026-06-01
• Completion: 2027-02-01
• First posted: 2025-09-10
• Last updated: 2025-09-10

Locations

5 sites across 1 country: South Korea