Using LSALT peptide to prevent kidney injury in heart surgery patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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) Completed
• Kosuyolu High Specialization Training and Research Hospital
  Kartal, Istanbul, Turkey (Türkiye) Completed

Study contacts

• Study coordinator: Richard Muruve
• Email: rm@archbiopartners.com
• Phone: +1 647 428 7031

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.