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.
19 to 90 years of age
Participants with aortic disease scheduled for cardiac surgery via total circulatory arrest (TCA)
Body weight ≥ 30 kg
Participants with vital signs within the following ranges
Participants scheduled for emergent or salvage cardiac surgery
Use of kidney replacement therapy (KRT) or presence of acute kidney injury (AKI)
Participants at risk of bleeding
Participants who underwent cardiac surgery via mid-sternotomy or thoracotomy, including major congenital heart disease