Phase 2a Study of BX-001N to Prevent Acute Kidney Injury and Major Kidney Events After Cardiac Surgery Using Total Circulatory Arrest

What this Trial Is About

This trial evaluates BX-001N, an investigational drug, to prevent acute kidney injury CSA-AKI and major adverse kidney events MAKE following cardiac surgery. It is a randomized, single-blind, multi-center, placebo-controlled phase 2a study involving approximately 50 adults aged 19 to 90 years with aortic disease scheduled for cardiac surgery using total circulatory arrest. The study aims to assess the drugs effects on kidney function markers and adverse kidney events after surgery. Participants will be assigned to one of four groups two experimental groups receiving either low or high doses of BX-001N intravenously once daily for three days, and two placebo groups receiving matching placebo infusions on the same schedule. Hospitalization for the study lasts from one day before surgery through Day 7, during which the investigational product is administered. Follow-up visits continue up to Day 90 to monitor efficacy and safety. During the study, participants will have regular assessments including measurements of kidney injury biomarkers such as NGAL, serum creatinine, estimated glomerular filtration rate eGFR, cystatin C, TIMP-2, IGFBP7, and blood urea nitrogen BUN. Researchers will also track major adverse renal events through Day 90. Safety and adherence will be monitored throughout, with follow-up visits conducted at the study site to evaluate participant health and kidney function after treatment ends.

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)