LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorArch Biopartners Inc.
About this trial
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.
Eligibility criteria
Qualifiers
Male and female ≥ 18 years of age.
Coronary artery bypass graft (CABG) alone
CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair
Aortic valve replacement or repair alone, with or without aortic root repair
Disqualifiers
The presence of AKI (KDIGO criteria) at the time of randomization
Off-pump cardiac surgery
Surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature < 28°C (82.4° F)
Severe chronic kidney disease: CKD-eGFR < 30 mL/min/1.73 m2) OR requiring dialysis
Trial design
Treatments tested in this trial
- LSALT Peptide
- Placebo
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov