DIALysis With EXpanded Solute Removal (NCT06660277) | Clinical Trial Compass
RecruitingNot Applicable
DIALysis With EXpanded Solute Removal
Canada4,800 participantsStarted 2025-08-12
Plain-language summary
The goal of this clinical trial is to evaluate the health effects of expanded hemodialysis in patients receiving hemodialysis. The main question it aims to answer is:
1\) Does expanded hemodialysis reduce the risk of death from any cause?
Researchers will compare expanded hemodialysis to conventional hemodialysis (the treatment currently used for the majority of patients receiving hemodialysis) to see if expanded hemodialysis works to improve patient outcomes.
Participants will continue to receive their regularly scheduled hemodialysis treatments using either a super high-flux/expanded dialysis filter or a high-flux/conventional dialysis filter. All other aspects of treatments remain the same. No additional tests or visits are required. Data will be obtained using administrative healthcare databases and medical record review (at a subset of participating locations).
Who can participate
Age range
45 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
. One of:
. Age 60 years or older; or
. Age 45 to 59 years with a history of diabetes mellitus (Type 1 or Type 2) regardless of current glycemic status; and
. Receiving any form of dialysis regularly for the previous 90 days; and
. Currently receiving HD in-centre (main or satellite unit) 3 or more times per week; and
. A valid provincial or territorial health insurance card number.
Exclusion criteria
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
Primary Outcome of All-Cause Mortality
Timeframe: From randomization to event (death) or end of treatment (average 2.9 years follow-up), whichever occurs first
Trial details
NCT IDNCT06660277
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
. Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to any of:
. Known or anticipated intolerance to the Nipro Elisio HX dialyzer; or
. Planned to receive HDF; or
. Planned to receive nocturnal HD; or
. Anticipated to discontinue in-centre HD in the next 3 months for any reason (examples: palliation, transplantation, home dialysis, recovery of kidney function, death, others); or
. Anticipated severe non-adherence to the frequency or duration of prescribed dialysis treatment; or
. An overriding clinical preference for expanded HD (i.e., dialysis with the Elisio HX or other comparable dialyzer, such as Baxter TheranovaTM); or
. Another medical, psychosocial, or logistical reason; or