RecruitingPHASE2INTERVENTIONAL

Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.

If you're on kidney dialysis, you might have noticed some changes in your memory or how quickly you think. This study, called AVAIL, is exploring whether a new drug, AV-001, can help protect your brain from these changes often linked to dialysis. Scientists believe it might work by making blood vessels in the brain stronger and reducing swelling. By taking part, you could help researchers discover ways to keep the brains of people on dialysis healthier, potentially lowering the risk of memory problems and strokes. This is an early stage study, looking for around 60 adults who've been on dialysis for at least three months.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

London Health Sciences Centre Research Institute

Enrolment target

Start

16 Dec 2025

Estimated completion

31 Dec 2027

Hemodialysis

What is this study about?

When you have regular dialysis treatment for your kidneys, it can sometimes affect your brain. Some people find they have trouble remembering things, think a bit slower, or feel a bit foggy in their thoughts. This is a common issue, and for some people, it can become quite noticeable even within a few months of starting dialysis. The medical term for this is cognitive decline.

Researchers are investigating whether a new medication, called AV-001, could help prevent this brain damage. They think this drug might work by making the tiny blood vessels in the brain stronger and reducing any inflammation (swelling) that dialysis might cause. If this drug proves successful, it could offer a new way to protect the brains of many people who rely on regular dialysis.

This early-stage study, known as AVAIL, is a crucial step in understanding whether AV-001 could be a game-changer. The aim is to see if it truly helps reduce the risk of memory loss and potentially even strokes in people undergoing long-term dialysis. Your participation could contribute significantly to finding better ways to support the health and well-being of people with kidney disease.

Key takeaways

This study explores a new drug (AV-001) for people on kidney dialysis.
It aims to protect the brain from memory and thinking problems linked to dialysis.
Participation involves injections during three dialysis sessions over one week.
You'll have assessments like blood tests, memory tests, and scans (ultrasound, MRI).
It's an early-stage study (Phase 2) to see if the drug is safe and effective.
Your involvement could help improve future care for dialysis patients.

Who may be eligible?

To join this study, you need to be an adult (over 18 years old) and able to understand and agree to take part. You must have been receiving regular kidney dialysis for at least three months, specifically three times a week on certain days (like Monday, Wednesday, and Friday).

There are also some reasons why you might not be able to join. For example, if you've been on dialysis for less than 90 days, or if you can't have an MRI scan (a type of body scan). You also can't take part if you already have severe memory problems or a diagnosis of dementia, or if you've had a stroke in the past. Women who are pregnant, breastfeeding, or planning to become pregnant also cannot participate.

Finally, if your blood pressure has dropped very low during dialysis recently, causing symptoms that needed treatment in the last month, you wouldn't be able to join either. The study is looking for both men and women.

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.

Are you over 18 years old?
Have you been on regular kidney dialysis for at least 3 months?
Do you have dialysis three times a week?
Can you have an MRI scan?
Are you able to understand and agree to take part?
Are you a woman who is not pregnant, breastfeeding, or planning to become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't need to change your usual dialysis schedule. The study will involve you receiving injections of either the study drug (AV-001) or a placebo (a dummy injection with no active drug) shortly before three of your dialysis sessions within one week (for example, on Monday, Wednesday, and Friday).

During the study, several assessments will be carried out. These include routine checks of your blood pressure and heart rate, and taking blood samples. You'll also have some tests to look at your memory and thinking skills. Researchers will use a special scan called a vascular ultrasound to examine your blood vessels and you will also have an MRI scan, which creates detailed pictures of your brain. The exact number of visits and the total duration aren't specified but involve measurements around those three dialysis sessions.

Potential risks and benefits

Taking part in a study like this means you might receive a new drug that could potentially help protect your brain from the effects of dialysis. However, because it's a new drug, there might be side effects that are not yet fully known. Some people will receive a placebo, meaning they won't get the active drug, but their involvement is still crucial for comparing results. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

London Health Sciences Centre
Verified postcode
London, Canada· Recruiting

Common questions

What is hemodialysis and why does it affect the brain?

Hemodialysis is a treatment that cleans your blood when your kidneys can't. Sometimes, over time, dialysis can put stress on your body and brain, potentially leading to mild memory or thinking problems.

What is AV-001?

AV-001 is a new medication being tested. Researchers hope it can protect the brain during dialysis by strengthening blood vessels and reducing inflammation.

What does 'Phase 2' mean?

Phase 2 means this is an early stage of testing for the drug. Researchers are looking to see if it's safe and effective before potentially testing it on more people.

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

No, you won't know if you're getting AV-001 or the placebo. This is to ensure the results are unbiased and accurate. You'll receive an injection whether it's the drug or the placebo.

How long will I be in the study for?

The description highlights receiving injections over one week (Monday, Wednesday, Friday), with assessments during this period. The full duration of your participation beyond that week isn't specified in detail.

How to find out more

Jarrin D Penny, PhD, RN

jarrin.penny@lhsc.on.ca 519-685-8500 Official trial record

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