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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
LSALT Peptide
DrugLSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity, potentially minimizing off-target or other adverse effects. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver.
Placebo
Drug0.9% saline solution
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: LSALT PeptideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
7 daysSecondary outcomes
1
Maximum severity of AKI per patient between treatment groups
1. Stage 1: SCr 1.5 - 1.9 times baseline OR ≥26.5 μmol/L (≥0.3 mg/dL) increase OR urine output \<0.5 mL/kg/hr for 6-12 hours 2. Stage 2: SCr 2.0 - 2.9 times baseline OR urine output \<0.5 mL/kg/h for ≥ 12 hours 3. Stage 3: SCr ≥3.0 times baseline OR increase in SCr of ≥26.5 μmol/L (≥0.3 mg/dL) to ≥353.6 μmol/L (≥4.0 mg/dL) OR initiation of renal replacement therapy (RRT) OR urine output \<0.3 mL/kg/h for ≥24 hours OR anuria for ≥12 hours.
Time frame
7 days2
Time to mild, moderate, and severe AKI per patient between treatment groups
Time frame
7 days3
Need for RRT within the first 7 days following surgery
Time frame
7 days4
Need for RRT at any time during the 28-day study
Time frame
28 daysSponsors and contacts
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Source ClinicalTrials.gov