RecruitingNot ApplicableNCT06032208

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

An Extension of an Interventional Study to Assess the Effect of Expanded Dialysis (HDx-Theranova) on Patient Reported Symptoms Using London Evaluation of Illness (LEVIL)


Sponsor

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

Enrollment

100 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Investigators know that many patients who are on dialysis suffer from burden of unwanted symptoms, which can affect quality of life. The understanding and treatment of symptom burden by healthcare providers is limited and should be recognized as a high priority in the care of the dialysis population. In this study, the investigators will be assessing symptom burden using the London Evaluation of Illness "LEVIL," an application based platform where patients self-report their symptoms with one to three hemodialysis treatments per week for 28 weeks. The investigators would like to compare the currently available dialyzer with a new dialyzer that is capable of removing solutes of higher molecular weight that may or may not cause patients to experience symptoms related to increased amounts of toxins in their blood.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a newer, expanded form of dialysis improves symptoms and quality of life for patients on regular kidney dialysis, compared to standard dialysis. Participants will report on their own symptoms through a special app or questionnaire called LEVIL. **You may be eligible if...** - You are 18 or older - You have been on regular hemodialysis (3 times per week) for at least 3 months - You are willing and able to give consent **You may NOT be eligible if...** - You have an active infection (you may join once it clears) - You are currently receiving daily dialysis or other specialized forms of dialysis (like hemodiafiltration) - You have significant vision impairment - You have a history of stroke or neurocognitive impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETheranova Dialyzer

The Theranova dialyzer will be used for each of the hemodialysis treatments beginning week 5 and ending at the end of dialysis week 28. This will allow us to compare patient reported symptoms in weeks 1-4 on their usual dialyzer with with their symptoms on the Theranova dialyzer.


Locations(2)

Victoria Hospital, London Health Sciences Centre

London, Ontario, Canada

Westmount Kidney Care Centre

London, Ontario, Canada

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NCT06032208


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