Super High-Flux Dialyzer: A hemodialysis filter (known as a dialyzer) that is currently approved by Health Canada and available for use across Canada. This filter has larger pores than a high-flux dialyzer that allow for greater removal of potential toxins and wastes in the blood that would regularly be filtered out by healthy kidneys.
High-Flux Dialyzer: A hemodialysis filter (known as a dialyzer) that is that is widely used across Canada for hemodialysis treatments.
Study 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).
Eligibility
Sex
ALL
Min age
45 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Inclusion requires that all the following are present:
1. One of:
1. Age 60 years or older; or
2. Age 45 to 59 years with a history of diabetes mellitus (Type 1 or Type 2) regardless of current glycemic status; and
2. Receiving any form of dialysis regularly for the previous 90 days; and
3. Currently receiving HD in-centre (main or satellite unit) 3 or more times per week; and
4. A valid provincial or territorial health insurance card number.
Exclusion Criteria: Patients are ineligible if they meet any of the following criteria:
1. Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to any of:
1. Known or anticipated intolerance to the Nipro Elisio HX dialyzer; or
2. Planned to receive HDF; or
3. Planned to receive nocturnal HD; or
4. 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
5. Anticipated severe non-adherence to the frequency or duration of prescribed dialysis treatment; or
6. An overriding clinical preference for expanded HD (i.e., dialysis with the Elisio HX or other comparable dialyzer, such as Baxter TheranovaTM); or
7. Another medical, psychosocial, or logistical reason; or
2. Enrolled in another clinical trial that explicitly prohibits concurrent participation in other clinical trials or that would substantially interfere with adherence to the DIALEX procedures (note that DIALEX otherwise permits concurrent participation in other trials); or
3. Previously enrolled in this trial; or
4. Declined participation.
Primary outcome measure(s)
Primary Outcome of All-Cause Mortality — From randomization to event (death) or end of treatment (average 2.9 years follow-up), whichever occurs first Outcome data will be collected as a result of routine patient interactions with the healthcare system and will be obtained from national and provincial data repositories (with the exceptions of routine care symptoms and ESA utilization outcomes, in participating sites), enabling health records to be analyzed in a privacy-compliant manner. These datasets have high levels of completeness and validity. The primary outcome, all-cause mortality, is captured with over 99% accuracy in our data sources.
Trial sites (3)
Facility
City
Region
Status
London Health Sciences Centre
London
Ontario
Recruiting
Orillia Soldiers' Memorial Hospital
Orillia
Ontario
Recruiting
The Ottawa Hospital
Ottawa
Ontario
Active Not Recruiting
More London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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