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 study identifier
interventional
50
1 country
8
Study Start
August 26, 2025
Actual (reported)Primary Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 26, 2025
Actual (reported)August 27, 2025
Actual (reported)September 10, 2025
Actual (reported)September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change from baseline in NGAL levels
Baseline(Day -1) to Day 7
Change from baseline in sCr levels
Baseline(Day -1) to Day 7
Change from baseline in eGFR
Baseline(Day -1) to Day 30
Change from baseline in CysC
Baseline(Day -1) to Day 7
Change from baseline in TIMP-2
Baseline(Day -1) to Day 7
Change from baseline in IGFBP7
Baseline(Day -1) to Day 7
Collection of Major Adverse Renal Events [MAKE]
Up to Day 90
Change from baseline in Incidence of AKI based on Kidney Disease: Improving Global Outcomes [KDIGO] criteria
Baseline(Day -1) to Day 7
Three low doses of BX-001N once a day on the scheduled date
Three high doses of BX-001N once a day on the scheduled date
Three low doses of placebo once a day on the scheduled date
Each participant will receive BX-001N at a weight-based low dose via IV injection once daily for a total of three administrations.
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.
Keimyung University Dongsan Medical Center
Daegu, 42601, South Korea
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
Myung Lip Kim, Chief Executive Officer
Bilix Co.,Ltd.
First Submitted
August 27, 2025
First Posted
September 10, 2025
Study Start
August 26, 2025
Actual (reported)Primary Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Three high doses of placebo once a day on the scheduled date
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Seoul Asan Medical center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Pusan National University Yangsan Hospital
Yangsan, 50612, South Korea
Study Completion
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 1, 2026
Record last verified: 2026-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: