RecruitingNAINTERVENTIONAL

An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL

Many people on dialysis experience uncomfortable symptoms that can lower their quality of life. This study aims to find out if a new type of dialysis filter, called Theranova, can help reduce these symptoms. The Theranova filter is designed to remove larger waste products from the blood than standard filters. Researchers want to see if removing these extra waste products makes patients feel better. Participants will use a special app called LEVIL every week to report their symptoms. This allows researchers to see immediately if the new filter has a positive effect on how people feel. The study will last 28 weeks.

At a glance

Status

Recruiting

Phase

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

100

Start

01 Mar 2024

Estimated completion

31 Dec 2026

End Stage Renal Disease

What is this study about?

If you're on dialysis, you know that managing the condition can come with a lot of challenges, including bothersome symptoms that can affect how you feel day-to-day. Doctors and nurses are always looking for ways to improve treatment and make life better for people on dialysis. This study is exploring a new approach that might help with those symptoms.

The main idea behind this research is to test a new kind of dialysis filter, called Theranova. Standard dialysis filters remove many waste products from your blood, but this new Theranova filter is designed to remove even more, including some larger waste products that current filters might miss. Scientists wonder if these larger waste products contribute to the symptoms people experience, and if removing them could make a real difference in how you feel.

To see if this new filter helps, participants will regularly report how they are feeling using a special app called LEVIL. This app makes it easy for you to share your symptoms, and the information goes straight to the researchers. This helps them track any changes very quickly. The study will last about 28 weeks, and the researchers are hoping to find out if using the Theranova filter can lead to an immediate improvement in how patients feel and their overall quality of life.

Key takeaways

Tests a new dialysis filter called Theranova to potentially reduce symptoms.
Uses a mobile app (LEVIL) to easily track how you feel.
Participation lasts about 28 weeks with regular symptom reporting.
Aims to see if removing more waste products improves patient well-being.
Helps researchers understand how new filters affect quality of life.

Who may be eligible?

This study is looking for volunteers who are currently receiving regular dialysis treatment, three times a week. To join, you need to have been on dialysis for at least three months. You also need to be 18 years old or older and be willing to understand and sign a consent form.

There are some reasons why you might not be able to join. For example, if you have an active infection, you won't be able to participate until it's cleared up. If you receive daily dialysis, or if you regularly have different types of blood filtering treatments (like Hemodiafiltration, Hemofiltration, or Isolated ultrafiltration), this study might not be suitable for you. Also, if you have severe eyesight problems, a history of problems with your memory or thinking, or if you've had a stroke, you won't be able to join.

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 18 years old or older?
Have you been on regular dialysis (3 times a week) for at least 3 months?
Do you currently have a serious infection?
Do you have a history of major memory or thinking problems, or a stroke?
Do you get your dialysis daily, or have other special filtration treatments often?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be involved for about 28 weeks. For the entire 28 weeks, you will use a special app called LEVIL to record your symptoms during one to three of your dialysis treatments each week. This is where you'll tell the researchers how you're feeling.

After the first four weeks, from week 5 until the end of the study at week 28, you will start using the new Theranova dialyzer during your regular dialysis sessions. You will also have two additional appointments outside of your regular dialysis. One will be at the very beginning of the study (between weeks 1 and 4) and another at week 28. At these appointments, you will complete some tests to check your thinking and memory, and you'll also fill out a questionnaire about sexual desire.

Potential risks and benefits

Taking part in a study like this means you're helping us learn more about dialysis and how to improve care for patients. A potential benefit could be that the new filter helps you feel better and reduces your symptoms, improving your quality of life, although we don't know for sure if it will. There are no major risks connected to using the Theranova filter beyond those of standard dialysis, as it's an approved device. It's really important to remember that joining any study is completely voluntary, and you are free to change your mind and stop participating at any time without it affecting your medical care.

Locations (4)

Seven Oaks Hospital Chronic Disease Innovation Centre Inc. (CDIC)
Verified postcode
Winnipeg, Canada· Recruiting
QEII Health Sciences Centre, Nova Scotia Health
Verified postcode
Halifax, Canada· Recruiting
Victoria Hospital, London Health Sciences Centre
Verified postcode
London, Canada· Recruiting
Westmount Kidney Care Centre
Verified postcode
London, Canada· Recruiting

Common questions

What is the new Theranova filter?

It's a special filter used during dialysis that can remove more types of waste products from your blood, including some larger ones that regular filters might miss.

How will I report my symptoms?

You'll use a user-friendly app called LEVIL. You just enter how you're feeling during some of your dialysis treatments each week.

How long will I be in the study?

The study lasts for 28 weeks, which is about 6 and a half months.

Do I have to pay for anything if I join?

No, the company providing the filter will cover any extra costs linked to using the new filter to make sure it doesn't cost you more.

What if I don't feel better with the new filter?

This is exactly what the study is trying to find out. Even if you don't feel a direct improvement, your participation still provides valuable information that helps researchers understand the effects better.

How to find out more

Christopher McIntyre, MBBS DM

christopher.mcintyre@lhsc.on.ca 5196858500 Official trial record

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