A Phase 2 interventional study of LSALT Peptide and Placebo in Acute Kidney Injury and Cardiac Surgery, sponsored by Arch Biopartners Inc.. Recruiting at 9 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Arch Biopartners Inc. · Phase 2, Interventional, and Prevention
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:
This study is a randomized, double-blind, multicenter interventional study to assess safety and efficacy of LSALT peptide versus placebo (matching drug-free saline) in patients undergoing on-pump cardiac surgery. Patients will be followed for safety and efficacy up to Day 28 (EOS), with Day 1 being the day of randomization of study drug administered at least 1 hour prior to induction of anesthesia.
A total of 240 patients will be included in the study, 120 patients each will be randomized to LSALT peptide or placebo. This study will be double-blinded with only the pharmacist at the site unblinded for the purpose of preparing drug/placebo for injection.
All subjects will undergo tests during the Screening period (window days -14 to Day 1). After satisfying all inclusion and exclusion criteria, the patient will be randomized equally to the following study arms:
Study treatment will be initiated pre-operatively on Day 1 and continued for 5 days. Physical examinations, vital signs and urine output will be recorded daily throughout the treatment period and on days 6 and 7. Adverse events will be recorded daily throughout the treatment period, on Days 6, 7, and 28 EOS (Day 28). Kidney function (serum creatinine, serum cystatin C, and BUN), clinical laboratory tests, and other biomarkers will be assessed at baseline (prior to initiation of study drug) and monitored daily throughout the treatment period, on Days 6, 7, and EOS (Day 28). All patients will be maintained on the standard of care (SOC) as per institutional guidelines. Thus, SOC will be followed in each patient with the addition of LSALT peptide or placebo.
Subjects will be followed until EOS (Day 28 ± 3 days) to assess renal function as discussed above.
An independent Data and Safety Monitoring Board (DSMB) will evaluate patients on a continuing basis for primarily safety assessments. Per the DSMB Charter, the DSMB will meet at least monthly if not more frequently based upon enrollment throughout the study period.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's planned enrollment of 240 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Arch Biopartners Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Scheduled for a non-emergent coronary and/or valve surgery procedure requiring on-pump cardiopulmonary bypass including but not limited to:
Have the following AKI risk factors:
CKD Stage 2 (CKD-EPI eGFR ≥ 60 and \< 90 mL/min/1.73 m2) and ONE or more of the following additional risk factors:
Exclusion Criteria:
LSALT peptide 10 mg IV administered over 1 hour twice daily, every 12 ± 1 hour, for 5 days
Drug: LSALT Peptide
Placebo IV administered over 1 hour twice daily, every 12 ± 1 hour, for 5 days
Drug: Placebo
LSALT, 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.
Also known as: Metablok
0.9% saline solution
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 days
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 days
Time to mild, moderate, and severe AKI per patient between treatment groups
Time frame: 7 days
Need for RRT within the first 7 days following surgery
Time frame: 7 days
Need for RRT at any time during the 28-day study
Time frame: 28 days
Duration of AKI at 28 days (EOS)
Duration of AKI is defined as the number of days from start of AKI per KDIGO criteria to onset of resolution
Time frame: 28 days
Kidney function (SCr, eGFR) at 28 days (EOS)
Time frame: 28 days
28-day all-cause mortality
Time frame: 28 days
Composite of death, need for RRT, and/or persistent impaired renal function from baseline (MAKE [major adverse kidney event] criteria) at Day 28 (EOS)
Time frame: 28 days
ICU length of stay (in days)
Time frame: 28 days
Hospitalization length of stay (in days)
Time frame: 28 days
Incidence of new-onset lung or liver disorders following surgery
Time frame: 28 days
Change in baseline serum cystatin C, serum NGAL, serum IP-10, serum IL-1beta, serum IL-6, and serum IL-18 biomarker levels
Time frame: 28 days
Changes in urinary TIMP-2 and IGFBP7 biomarker and serum NGAL, AGT, and IL-18 biomarker levels
Biomarkers will be measured at baseline and days 1, 3, 5, and 7
Time frame: 7 days
Development of serum anti-drug antibodies levels throughout the study
Anti-drug antibodies will be measured at baseline (Day 1 prior to the first dose of study medication) and at days 1, 2, 3, 4, 5 and day 28 (EOS)
Time frame: 28 days
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