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

Launched by ARCH BIOPARTNERS INC. · May 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called LSALT Peptide to see if it can help prevent or reduce kidney problems, known as acute kidney injury (AKI), in patients who are undergoing heart surgery that requires the use of a heart-lung machine (on-pump cardiac surgery). AKI can occur when the kidneys don’t get enough blood flow during surgery, and it can lead to serious health issues. The trial will look at how many patients develop AKI within a week after their surgery based on specific kidney function tests.

To participate in this trial, you need to be at least 18 years old and scheduled for certain types of heart surgery, such as coronary artery bypass or valve replacement. You should also have some risk factors for kidney issues, like having chronic kidney disease or being over 75 years old. If you decide to join, you’ll receive the study drug and be monitored closely for any changes in your kidney function after your surgery. It’s important to know that there are some exclusions, such as having active kidney injury before starting the trial or needing surgery under specific conditions that could complicate the results. Overall, this study aims to find a way to help protect your kidneys during surgery and improve recovery outcomes.

Gender

ALL

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.