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RecruitingPHASE2INTERVENTIONAL

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

This research study is trying to find out if a new treatment, named LSALT peptide, can help protect the kidneys of patients undergoing heart surgery. Sometimes, after a certain type of heart surgery (called 'on-pump' surgery), people can develop a problem called Acute Kidney Injury (AKI), where their kidneys suddenly stop working as well as they should. This study will compare LSALT peptide to a 'placebo' (a dummy treatment with no active drug) to see if LSALT can reduce the chances of this happening or make it less severe. Around 240 patients will take part, some receiving LSALT and others the placebo, and their kidney health will be closely monitored for 28 days after surgery.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Arch Biopartners Inc.
Enrolment target
240
Start
08 Mar 2024
Estimated completion
01 Dec 2026

What is this study about?

This study is about protecting your kidneys if you need to have a specific type of heart surgery. Sometimes, after 'on-pump' cardiac surgery (where a special machine takes over your heart and lung function during the operation), a common problem can be Acute Kidney Injury, or AKI for short. This means your kidneys suddenly aren't working as well as they should.

Researchers are testing a new treatment called LSALT peptide. They want to see if giving this treatment before and after surgery can help prevent AKI or make it less serious if it does happen. Currently, there isn't a specific drug to prevent this kind of kidney injury during heart surgery, so finding an effective treatment could make a real difference for patients.

This study is a 'Phase 2' trial, which means it's an important step in learning more about the medication's safety and how well it works. The information from this study will help doctors decide if LSALT peptide should be tested in an even larger group of people in the future.

Key takeaways

  • This study evaluates a potential new drug (LSALT peptide) to protect kidneys during heart surgery.
  • It compares the new drug to a dummy treatment (placebo).
  • Participation involves receiving treatment and close monitoring for about 28 days.
  • You won't know if you're getting the active drug or the placebo.
  • The goal is to prevent or reduce Acute Kidney Injury (AKI) after 'on-pump' heart surgery.

Who may be eligible?

This study is looking for adults aged 18 or older who are scheduled for certain types of planned (not emergency) heart surgery involving a heart-lung machine. This includes operations like coronary bypass surgery or valve replacements.

To join, you also need to have some risk factors that make it more likely for your kidneys to be affected by surgery. This might be if you have some existing kidney problems (even mild ones), are over 75, are having a combination of valve and coronary surgery, have a certain heart condition (weakened pumping ability), or have conditions like diabetes, high blood pressure, or high cholesterol.

Women who could become pregnant must be using effective birth control during the study. Pregnant or breastfeeding women cannot take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Are you scheduled for heart surgery that uses a heart-lung machine (on-pump)?
  3. Do you have certain risk factors for kidney problems, like mild existing kidney issues, being over 75, or having diabetes?
  4. Are you able to use effective birth control if you are a woman who could become pregnant?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have some screening checks up to two weeks before your surgery to make sure you're a good fit for the study. If you qualify, you'll be randomly assigned to receive either the LSALT peptide or a placebo (a dummy treatment that looks the same but has no active drug). You won't know which one you're getting, and neither will your doctors – this is called 'double-blind'.

The study medicine will be given through a drip for about an hour, twice a day for five days, starting at least one hour before your surgery begins. Throughout this time, and for a few weeks after, the study team will regularly check your physical health, vital signs (like blood pressure), and monitor your urine output. They will also take blood samples daily to check your kidney function and other health markers. You'll continue to receive all the standard care your hospital would normally provide. Your safety and kidney function will be followed up until about 28 days after your surgery.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as helping researchers find new ways to protect kidneys during heart surgery, which could benefit future patients. You will also receive very close monitoring of your kidney function and overall health. However, there's no guarantee that you will personally benefit from the treatment. All medications carry potential risks and side effects, and these will be carefully explained to you. You might experience side effects from the study drug, or even from the placebo. Remember, joining this study is completely voluntary, and you are free to withdraw at any time without it affecting your medical care.

Locations (9)

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

Common questions

What is 'Acute Kidney Injury'?

Acute Kidney Injury (AKI) is when your kidneys suddenly stop working as well as they should. It can happen after major surgery and usually gets better, but it can sometimes be serious.

What is LSALT peptide?

LSALT peptide is a new experimental drug being tested to see if it can help protect kidneys from injury, especially around the time of heart surgery.

What is a 'placebo'?

A placebo is a dummy treatment. It looks just like the real medicine but contains no active drug. It helps researchers compare the effects of the active drug accurately.

Will I know if I'm getting the real drug or the placebo?

No, neither you nor your doctors will know if you're receiving LSALT peptide or the placebo. This is to make sure the study results are fair and unbiased.

How long will I be involved in the study?

You'll receive the study treatment for 5 days around your surgery, and your health will be monitored for a total of about 28 days after your operation.

How to find out more

Richard Muruve

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "LSALT Peptide for Prevention or Attenuation of Acute Kidney …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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