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.
This study will enroll approximately 50 participants, with 16 participants randomized to Experimental Group 1 and 4 participants to the Placebo Group 1, 15 participants to Experimental Group 2 and 15 participants to the Placebo Group 2. Randomized participants will be hospitalized from one day prior to surgery (Baseline, Day -1) through Day 7. Investigational product (IP) (i.e., BX-001N) will be administered intravenously at a weight-based dose as follows: The test drug will be administered three times in total. Participants in the Placebo Group will receive placebo at the same time points and in the same manner. Follow-up visits will be conducted up to Day 90 at the study site for scheduled efficacy and safety assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
50
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.
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.
Keimyung University Dongsan Medical Center
Daegu, South Korea
NOT_YET_RECRUITINGSeoul National University Bundang Hospital
Seongnam, South Korea
NOT_YET_RECRUITINGKorea University Anam Hospital
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITINGSeoul Asan Medical center
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
NOT_YET_RECRUITINGPusan National University Yangsan Hospital
Yangsan, South Korea
RECRUITINGChange from baseline in NGAL levels
Time frame: Baseline(Day -1) to Day 7
Change from baseline in sCr levels
Time frame: Baseline(Day -1) to Day 7
Change from baseline in eGFR
Time frame: Baseline(Day -1) to Day 30
Change from baseline in CysC
Time frame: Baseline(Day -1) to Day 7
Change from baseline in TIMP-2
Time frame: Baseline(Day -1) to Day 7
Change from baseline in IGFBP7
Time frame: Baseline(Day -1) to Day 7
Collection of Major Adverse Renal Events [MAKE]
Time frame: Up to Day 90
Change from baseline in Incidence of AKI based on Kidney Disease: Improving Global Outcomes [KDIGO] criteria
\[Staging of AKI\] Stage 1 : 1.5-1.9 times baseline or ≥0.3mg/dL increase Stage 2 : 2.0-2.9 times baseline Stage 3 : 3.0 times baseline or increase in serum creatinine to ≥4.0mg/dL or Initiation of renal replacement therapy
Time frame: Baseline(Day -1) to Day 7
Change from baseline in BUN
Time frame: Baseline(Day -1) to Day 30
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