Phase 2 Study of LSALT Peptide to Prevent or Reduce Acute Kidney Injury in Adults Having On-Pump Heart Surgery

What this Trial Is About

Researchers are studying the use of LSALT peptide to prevent or reduce acute kidney injury AKI in patients undergoing on-pump cardiac surgery. This trial evaluates how often AKI occurs within 7 days after such surgery, using established kidney function criteria. The study is a randomized, double-blind, placebo-controlled Phase 2 trial involving patients at risk of AKI due to their kidney function or other health factors. Participants will be randomly assigned to receive either the LSALT peptide or a placebo. The LSALT peptide is given intravenously at 10 mg over one hour twice daily for five days, starting at least one hour before anesthesia begins. The placebo group receives a matching saline solution on the same schedule. Standard care continues alongside the study treatments, and safety is closely monitored by an independent board. Throughout the study, participants will have daily physical exams, vital sign checks, and urine output monitoring during the treatment period and shortly after. Kidney function tests and biomarker assessments occur at baseline and regularly through 28 days after surgery. Adverse events are recorded daily during treatment and on follow-up days. The study tracks kidney injury severity, need for kidney replacement therapy, mortality, hospital stay length, and other health outcomes to understand the treatments effects.

LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery