An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL (NCT06032208) | Clinical Trial Compass
RecruitingNot Applicable
An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL
Canada100 participantsStarted 2024-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Conventional thrice weekly HD schedule
* Must be on chronic hemodialysis for at least 3 months
* Age ≥18 years
* Willing and able to give informed consent
Exclusion Criteria:
* Active infection (may enroll once infection is cleared)
* Patients receiving daily hemodialysis treatment
* Patients currently receiving Hemodiafiltration (HDF), Hemofiltration (HF) or Isolated ultrafiltration (ISO UF) more than once in three months
* Visual impairment
* History of neurocognitive impairment
* History of stroke (CVA)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx -Theranova) effects patient reported symptoms as determined by LEVIL.
Timeframe: Beginning week 1 and ending at the end of dialysis on week 28.
Trial details
NCT IDNCT06032208
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's