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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Acute Kidney Injury, Cardiac Surgery

In brief

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.

Key facts

Study ID

NCT05879432

Run by

Arch Biopartners Inc.

People needed

240

Starts

2024-03-08

Expected to finish

2027-08-01

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Hypertension
• Hyperlipidemia
• 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.
• 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.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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