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)

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 26, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

February 28, 2027

Conditions
Ischemia Reperfusion InjuryCardiac Surgery Associated - Acute Kidney Injury
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.

Trial Locations (5)

50612

NOT_YET_RECRUITING

Pusan National University Yangsan Hospital, Yangsan

02841

NOT_YET_RECRUITING

Korea University Anam Hospital, Seoul

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

NOT_YET_RECRUITING

Severance Hospital, Seoul

05505

NOT_YET_RECRUITING

Seoul Asan Medical center, Seoul

All Listed Sponsors
lead

Bilix Co.,Ltd.

INDUSTRY

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) | Biotech Hunter | Biotech Hunter