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Prevention study for Acute Kidney Injury
Official title LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery
ClinicalTrials.gov ID: NCT05879432
What this study is testing
What is LSALT Peptide?
LSALT Peptide is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute kidney injury.
Also referred to as Metablok.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- New Westminster, British Columbia, Canada
- Toronto, Ontario, Canada
- Yenimahalle, Ankara, Turkey (Türkiye)
- Kartal, Istanbul, Turkey (Türkiye)
- Melikgazi, Kayseri, Turkey (Türkiye)
- İzmit, Kocaeli, Turkey (Türkiye)
- Kahramanmaraş, Onikişubat, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; New Westminster, British Columbia, Canada; Toronto, Ontario, Canada; Yenimahalle, Ankara, Turkey (Türkiye); Kartal, Istanbul, Turkey (Türkiye); Melikgazi, Kayseri, Turkey (Türkiye) and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.