Using LSALT peptide to prevent kidney injury in heart surgery patients

Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT Peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery

This study is testing if a new peptide can help prevent kidney injury in patients having heart surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Arch Biopartners Inc. (Industry-sponsored)
• Locations: 9 sites (Calgary, Alberta and 8 other locations)
• Trial ID: NCT05879432 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of LSALT peptide in preventing or reducing acute kidney injury (AKI) in patients undergoing on-pump cardiac surgery. It is a randomized, double-blind, multicenter study involving 240 participants who will receive either the LSALT peptide or a placebo prior to surgery. The study will monitor kidney function and safety outcomes for 28 days following the surgery, with specific criteria for AKI defined by established guidelines. Participants will be closely observed for any adverse events and changes in kidney-related biomarkers throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adults scheduled for non-emergent cardiac surgeries that require on-pump cardiopulmonary bypass and have risk factors for acute kidney injury.

Not a fit: Patients who are not undergoing on-pump cardiac surgery or do not have the specified risk factors for AKI may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of acute kidney injury in patients undergoing cardiac surgery, improving overall recovery and outcomes.

How similar studies have performed: Other studies have explored similar interventions for preventing AKI in surgical patients, showing promising results, but this specific approach with LSALT peptide is novel.

Eligibility criteria

Inclusion Criteria:

1. Male and female ≥ 18 years of age.
2. 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.
3. 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
     * Hypertension
     * Hyperlipidemia
4. Sexually active women of child-bearing potential (WCBP) must be using a medically acceptable method of birth control throughout the study and for at least 1 day following the end of study and have a negative urine pregnancy test at the Screening visit. A WCBP is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or the implant. In patients who are not sexually active, abstinence is an acceptable form of birth control and urine will be tested per protocol. Women who are of nonchild-bearing potential, i.e., post-menopause, must have this condition captured in their medical history. Pregnant women and nursing mothers are excluded from this study.
5. Patient or Legally Authorized Representative (LAR) is available and willing to give written informed consent, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures.

Exclusion Criteria:

1. The presence of AKI (KDIGO criteria) at the time of randomization
2. Off-pump cardiac surgery
3. Surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature \< 28°C (82.4° F)
4. Severe chronic kidney disease: CKD-eGFR \< 30 mL/min/1.73 m2) OR requiring dialysis
5. Imminent or recent surgery for aortic dissection
6. 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)
7. Known history of active cancer which may interfere with interpretation of the results of this study
8. Known or suspected sepsis at time of screening
9. Pregnancy or lactation
10. Known hypersensitivity to the study drug or any of its excipients
11. 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
12. Any disease processes or confounding variables that would inappropriately alter the outcome of the study in the opinion of the investigator
13. Inability to comply with the requirements of the study protocol.

Where this trial is running

Calgary, Alberta and 8 other locations

• Cumming School of Medicine & Libin Cardiovascular Centre, University of Calgary — Calgary, Alberta, Canada (Recruiting)
• Royal Columbian Hospital — New Westminster, British Columbia, Canada (Recruiting)
• Unity Health Toronto, St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
• University Health Network, Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
• Gazi University — Yenimahalle, Ankara, Turkey (Türkiye) (Recruiting)
• Kosuyolu High Specialization Training and Research Hospital — Kartal, Istanbul, Turkey (Türkiye) (Recruiting)
• Erciyes University, Faculty of Medicine - Semiha Kibar Organ Transplant & Dialysis Hospital — Melikgazi, Kayseri, Turkey (Türkiye) (Recruiting)
• Kocaeli University, Faculty of Medicine Practices and Research Hospital — İzmit, Kocaeli, Turkey (Türkiye) (Recruiting)
• Sütçü İmam University, Faculty of Medicine — Kahramanmaraş, Onikişubat, Turkey (Türkiye) (Recruiting)

Study contacts

• Study coordinator: Richard Muruve

Conditions Acute Kidney Injury; Cardiac Surgery