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RECRUITING
NCT07164833
PHASE2

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)

Sponsor: Bilix Co.,Ltd.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

19 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-08-26

Completion Date

2027-02

Last Updated

2025-09-10

Healthy Volunteers

No

Interventions

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.

Locations (5)

Korea University Anam Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Seoul Asan Medical center

Seoul, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea