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

NCT05879432 | Recruiting Phase 2 FDA Drug

• 1 other identifier: AB003
• Study Type: interventional
• Target: 240
• Locations: 2 countries
• Sites: 9

Brief 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. 1.Increase in baseline (pre-surgery) serum creatinine (SCr) by ≥26.5 μmol/L (≥0.3 mg/dL) within 7 days; OR
2. 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. 3.Urine output \< 0.5 mL/kg/h for \>6 hours.

Conditions

Acute Kidney Injury; Cardiac Surgery

Outcome Measures

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.

  7 days

Secondary Outcomes (14)

• Maximum severity of AKI per patient between treatment groups

  7 days

• Time to mild, moderate, and severe AKI per patient between treatment groups

  7 days

• Need for RRT within the first 7 days following surgery

  7 days

• Need for RRT at any time during the 28-day study

  28 days

• Duration of AKI at 28 days (EOS)

  28 days

Study Arms (2)

LSALT Peptide

EXPERIMENTAL

LSALT peptide 10 mg IV administered over 1 hour twice daily, every 12 ± 1 hour, for 5 days

Drug: LSALT Peptide

Placebo

PLACEBO COMPARATOR

Placebo IV administered over 1 hour twice daily, every 12 ± 1 hour, for 5 days

Drug: Placebo

Interventions

LSALT Peptide DRUG

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

LSALT Peptide

Placebo DRUG

0.9% saline solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female ≥ 18 years of age.
• Scheduled for a non-emergent coronary and/or valve surgery procedure requiring on-pump cardiopulmonary bypass including but not limited to:
• 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
• Mitral, tricuspid, or pulmonic valve replacement or repair alone
• Simultaneous replacement of several cardiac valves.
• Have the following AKI risk factors:
• CKD Stage 3 (CKD-EPI eGFR ≥ 30 and \< 60 mL/min/1.73 m2) and ONE or more of the following additional risk factors OR
• CKD Stage 2 (CKD-EPI eGFR ≥ 60 and \< 90 mL/min/1.73 m2) and ONE or more of the following additional risk factors:
• Age ≥ 75 years;
• Combined valve \& coronary artery surgery;
• Left ventricular ejection fraction (LVEF) ≤ 35% by invasive or noninvasive techniques;
• Urinary (TIMP-2 x IGFBP7) \> 0.3
• Diabetes mellitus

You may not qualify if:

• 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
• Imminent or recent surgery for aortic dissection
• Surgery to correct a major congenital heart defect (e.g., Tetralogy of Fallot, transposition of the great vessels, single ventricle, or Ebstein's anomaly. Bicuspid aortic valve is not considered a congenital heart defect)
• Known history of active cancer which may interfere with interpretation of the results of this study
• Known or suspected sepsis at time of screening
• Pregnancy or lactation
• Known hypersensitivity to the study drug or any of its excipients
• Treatment with an investigational drug or participation in an interventional trial within 30 days prior to the first dose of study drug and throughout the study
• Any disease processes or confounding variables that would inappropriately alter the outcome of the study in the opinion of the investigator
• Inability to comply with the requirements of the study protocol.

Sponsors & Collaborators

• Arch Biopartners Inc.: lead

Study Sites (9)

Cumming School of Medicine & Libin Cardiovascular Centre, University of Calgary

Calgary, Alberta, T2N 4N1, Canada

RECRUITING

Royal Columbian Hospital

New Westminster, British Columbia, V3L 0A2, Canada

RECRUITING

Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G 1L7, Canada

RECRUITING

Gazi University

Yenimahalle, Ankara, 06560, Turkey (Türkiye)

RECRUITING

Kosuyolu High Specialization Training and Research Hospital

Kartal, Istanbul, 34865, Turkey (Türkiye)

RECRUITING

Erciyes University, Faculty of Medicine - Semiha Kibar Organ Transplant & Dialysis Hospital

Melikgazi, Kayseri, 38030, Turkey (Türkiye)

RECRUITING

Kocaeli University, Faculty of Medicine Practices and Research Hospital

İzmit, Kocaeli, 41001, Turkey (Türkiye)

RECRUITING

Sütçü İmam University, Faculty of Medicine

Kahramanmaraş, Onikişubat, 46040, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Richard Muruve

CONTACT

+1 647 428 7031; rm@archbiopartners.com

David Luke

CONTACT

dl@archbiopartners.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 30, 2023
• Study Start: March 8, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CA (4); TU (5)