drugset / Trial / NCT05879432

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

NCT05879432 ↗

Phase 2 Recruiting 240 enrolled Arch Biopartners Inc.
RandomizedSingle-groupTriple-blindPrevention

Summary

To evaluate the percentage of subjects with AKI within 7 days following on-pump cardiac surgery defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria: 1. Increase in baseline (pre-surgery) serum creatinine (SCr) by ≥26.5 μmol/L (≥0.3 mg/dL) within 7 days; OR 2. Increase in baseline SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the first 7 days following surgery; OR 3. Urine output \< 0.5 mL/kg/h for \>6 hours.

Timeline

Start
2024-03-08
Primary completion
2027-03
Completion
2027-08

Drugs

EvaluationDrugModalityDoseRoute
Subject LSALT Peptide 10 mg Intravenous

Indications