An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL (NCT06032208)
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)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (7 items).
Location: Seven Oaks Hospital Chronic Disease Innovation Centre Inc. (CDIC) — Winnipeg, Manitoba
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (4 Sites)
- Seven Oaks Hospital Chronic Disease Innovation Centre Inc. (CDIC) — Winnipeg, Manitoba
- QEII Health Sciences Centre, Nova Scotia Health — Halifax, Nova Scotia
- Victoria Hospital, London Health Sciences Centre — London, Ontario
- Westmount Kidney Care Centre — London, Ontario
📞 Contact the Study Coordinator
Phone: (519) 685-8500
Email: Christopher.McIntyre@lhsc.on.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.