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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)

NCT07164833 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-10

No results posted yet for this study

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.

Conditions

  • Ischemia Reperfusion Injury
  • Cardiac 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.

Sponsors & Collaborators

  • Bilix Co.,Ltd.

    lead INDUSTRY

Principal Investigators

  • Myung Lip Kim, Chief Executive Officer · Bilix Co.,Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2026-06-30
Completion
2027-02-28

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07164833 on ClinicalTrials.gov