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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.
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
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.
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.
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