Assessing the impact of a new dialysis method on patient symptoms
Official title: 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)
Run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · NCT06032208 · Data updated 2026-11-12
This study is testing a new dialysis method to see if it can help people with end-stage kidney disease feel better by reducing their symptoms during treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 4 sites (Winnipeg, Manitoba and 3 other locations) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT06032208 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who have been on chronic hemodialysis for at least three months and are on a conventional thrice-weekly schedule.
✕Probably not a fit
Patients receiving daily hemodialysis or those with active infections or significant cognitive impairments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effect of the Theranova dialyzer, which removes larger middle molecules, on the symptom burden experienced by patients undergoing hemodialysis for end-stage renal disease. Using the London Evaluation of Illness (LEVIL) application, patients will self-report their symptoms during their hemodialysis treatments over a 28-week period. The goal is to determine if this new dialyzer can improve patients' quality of life by reducing the symptoms associated with toxin accumulation in their blood. The study aims to provide real-time feedback on symptom changes, allowing for dynamic assessment of patient well-being.
Why it matters
Potential benefit: If successful, this study could lead to improved symptom management and quality of life for patients on dialysis.
How similar studies have gone: While the approach of using a new dialyzer is innovative, similar studies have not been extensively conducted, making this a novel investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
-
Seven Oaks Hospital Chronic Disease Innovation Centre Inc. (CDIC)
Winnipeg, Manitoba, Canada Recruiting -
QEII Health Sciences Centre, Nova Scotia Health
Halifax, Nova Scotia, Canada Recruiting -
Victoria Hospital, London Health Sciences Centre
London, Ontario, Canada Recruiting -
Westmount Kidney Care Centre
London, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Christopher McIntyre, MBBS DM — London Heath Sciences Centre
- Study coordinator: Christopher McIntyre, MBBS DM
- Email: Christopher.McIntyre@lhsc.on.ca
- Phone: 5196858500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.