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

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arch Biopartners Inc.

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 4 (CKD-EPI eGFR ≥ 15 and < 30 mL/min/1.73 m2) OR

• CKD Stage 3 (CKD-EPI eGFR ≥ 30 and < 60 mL/min/1.73 m2) and ONE of the following additional risk factors (below; excluding age ≥ 75 years) OR

• CKD Stage 2 (CKD-EPI eGFR ≥ 60 and < 90 mL/min/1.73 m2) and TWO 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;

• Diabetes mellitus on treatment;

• Albuminuria (random urine albumin:creatinine ratio >30 mg/mmol.

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. Stage 5 CKD (CKD-EPI eGFR <15 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

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.