Actively Recruiting
LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery
Led by Arch Biopartners Inc. · Updated on 2026-05-05
240
Participants Needed
9
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female 18 years of age or older
- Scheduled for non-emergent coronary and/or valve surgery requiring on-pump cardiopulmonary bypass, including CABG and valve replacements or repairs
- Have chronic kidney disease stage 3 (eGFR 30 to less than 60 mL/min/1.73 m2) with one or more additional risk factors, or stage 2 (eGFR 60 to less than 90 mL/min/1.73 m2) with one or more additional risk factors such as age 75 or older, combined valve and coronary surgery, low left ventricular ejection fraction (35% or less), elevated urinary biomarkers, diabetes, hypertension, or hyperlipidemia
- Sexually active women of child-bearing potential must use acceptable birth control throughout the study and have a negative pregnancy test at screening
- Patient or legally authorized representative available and willing to provide informed consent
You will not qualify if you...
- Acute kidney injury present at time of randomization
- Off-pump cardiac surgery
- Surgery under circulatory arrest or hypothermia with rectal temperature below 28°C
- Severe chronic kidney disease with eGFR below 30 mL/min/1.73 m2 or requiring dialysis
- Imminent or recent aortic dissection surgery
- Surgery to correct major congenital heart defects (except bicuspid aortic valve)
- Active cancer that may affect study results
- Known or suspected sepsis at screening
- Pregnancy or lactation
- Known allergy to study drug or its ingredients
- Participation in another interventional trial or investigational drug treatment within 30 days before study drug and during study
- Any disease or factors that could confound study outcomes as judged by the investigator
- Inability to comply with study protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Cumming School of Medicine & Libin Cardiovascular Centre, University of Calgary
Calgary, Alberta, Canada, T2N 4N1
Actively Recruiting
2
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 0A2
Actively Recruiting
3
Unity Health Toronto, St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
4
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 1L7
Actively Recruiting
5
Gazi University
Yenimahalle, Ankara, Turkey (Türkiye), 06560
Actively Recruiting
6
Kosuyolu High Specialization Training and Research Hospital
Kartal, Istanbul, Turkey (Türkiye), 34865
Actively Recruiting
7
Erciyes University, Faculty of Medicine - Semiha Kibar Organ Transplant & Dialysis Hospital
Melikgazi, Kayseri, Turkey (Türkiye), 38030
Actively Recruiting
8
Kocaeli University, Faculty of Medicine Practices and Research Hospital
İzmit, Kocaeli, Turkey (Türkiye), 41001
Actively Recruiting
9
Sütçü İmam University, Faculty of Medicine
Kahramanmaraş, Onikişubat, Turkey (Türkiye), 46040
Actively Recruiting
Research Team
R
Richard Muruve
CONTACT
D
David Luke
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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