RecruitingPhase 2NCT07164833

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)

Sponsor

Bilix Co.,Ltd.

Enrollment

50 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiac Surgery associated Acute kidney injury Ischemia Reperfusion Injury

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 50 participants.

Eligibility

Min Age: 19 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BX-001N Experimental group 1, a drug called BX-001N Experimental group 2, and others for people with cardiac surgery associated acute kidney injury and ischemia reperfusion injury. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 19 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBX-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.

DRUGBX-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.

DRUGPlacebo group 1

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.

DRUGPlacebo group 2

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.