An interventional study of Super High-Flux Dialyzer and High-Flux Dialyzer in Chronic Kidney Disease Requiring Hemodialysis, End-Stage Kidney Disease (ESKD) and Chronic Kidney Disease Requiring Chronic Dialysis, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Recruiting at 3 sites in Canada. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment
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).
Background:
Expanded hemodialysis refers to hemodialysis treatment using a newer generation of hemodialysis filters or "dialyzers" that remove large middle molecules to a greater extent than conventional "high-flux" dialyzers. This is expected to improve major health outcomes. However, despite a decade of availability and promising surrogate data from small trials and patient outcomes data from large observational studies, dialyzers capable of providing expanded hemodialysis have failed to achieve significant adoption conventional high-flux dialyzers in the absence of more definitive evidence. A large, rigorous randomized controlled trial is necessary to establish the clinical effectiveness of expanded hemodialysis compared to conventional hemodialysis with high-flux dialyzers.
Study Design:
Parallel, block randomized, controlled, open label, superiority trial comparing the clinical effects of expanded hemodialysis using Nipro Elisio HX dialyzers to conventional hemodialysis using high-flux dialyzers. The allocation ratio will vary between 1:3 or 1:1 ratio depending on their dialysis unit.
Setting:
Community and academic hemodialysis facilities.
Study Size:
4800 participants (1200 in expanded hemodialysis arm and 3600 in conventional high-flux hemodialysis arm) followed for a mean of 2.9 years.
Trial Duration:
Duration of participant accrual - 2 years from date of first participant recruited.
Total duration - 5 years from date of first participant recruited. Trial results anticipated to be announced in 2030.
Study Power:
90% power to detect 15% relative reduction in the hazard of death (hazard ratio 0.85).
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 4,800 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 331 studies on the registry; 137 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Inclusion requires that all the following are present:
One of:
Exclusion Criteria: Patients are ineligible if they meet any of the following criteria:
Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to any of:
Participants will receive their regularly scheduled hemodialysis treatments using a super high-flux dialyzer (Nipro Elisio HX).
Device: Super High-Flux Dialyzer
Participants will receive their regularly scheduled hemodialysis treatments using a high-flux dialyzer (as prescribed in routine care).
Device: 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.
Also known as: Expanded Hemodialysis, Nipro Elisio HX, Sharp Cut-Off Dialyzer, Medium Cut-Off Dialyzer
A hemodialysis filter (known as a dialyzer) that is that is widely used across Canada for hemodialysis treatments.
Also known as: Conventional Hemodialysis
Primary Outcome of All-Cause Mortality
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.
Time frame: From randomization to event (death) or end of treatment (average 2.9 years follow-up), whichever occurs first
Key Secondary Outcome of Cardiovascular and Infection-Related Hospitalizations
The key secondary outcome will be time to first and recurrent cardiovascular or infection-related hospitalizations. Cardiovascular and infection-related hospitalizations will be ascertained using primary discharge ICD-10 diagnosis codes in the Canadian Institute for Health Information Discharge Abstract Database
Time frame: From randomization to the end of treatment (average 2.9 year follow-up)
Cardiovascular-Related Hospitalizations
Time to first and recurrent cardiovascular hospitalizations. Each component of the secondary outcome (cardiovascular-related and infection-related hospitalizations) will be examined separately.
Time frame: From randomization to the end of treatment (average 2.9 year follow-up)
Infection-Related Hospitalizations
Time to first and recurrent infection-related hospitalizations. Each component of the secondary outcome (cardiovascular-related and infection-related hospitalizations) will be examined separately.
Time frame: From randomization to the end of treatment (average 2.9 year follow-up)
Death from Cardiovascular Cause
Defined as any out-of-hospital death or death that occurred during a hospitalization for a cardiovascular cause captured in Canada in the CIHI-DAD database.
Time frame: From randomization to end of treatment (average 2.9 year follow-up).
Death from Non-cardiovascular Cause
Death that does not meet the definition for death from a cardiovascular cause.
Time frame: From randomization to end of treatment (average 2.9 year follow-up).
Receipt of a Functional Kidney Transplant
Receipt of a functional kidney transplant is defined, in Canada, by a record of a hospital admission in the CIHI-DAD database with an ICD-10 code for kidney transplantation followed by discontinuation of dialysis in the absence of death. Receipt of a functioning kidney transplant refers to the first functioning transplant received after randomization.
Time frame: From randomization to event (functioning kidney transplant) or end of treatment (average 2.9 years follow-up), whichever comes first.
Routine Care Symptoms
Routine care symptoms assessed using the Edmonton Symptoms Assessment System Revised Renal (ESAS-r: Renal) instrument, as recorded in usual care. Data will be abstracted from routine clinical records. The ESAS-r: Renal evaluates 12 symptoms on a 0-10 scale, with assessments every 3-6 months. The minimum value is 0, meaning no experience of specified symptom. The maximum value is 10 meaning, worst possible experience of specified symptom. This will be done only in units that routinely administer this instrument and participation in reporting this outcome is optional for sites.
Time frame: From randomization to the end of treatment (average 2.9 year follow-up)
Healthcare-Associated Costs
The investigator will assess healthcare-associated costs in the subset of patients enrolled in Ontario using linked administrative databases with a standard method developed by the Institute for Clinical Evaluative Sciences (ICES).
Time frame: From randomization to the end of treatment (average 2.9 year follow-up)
Neutrophil to Lymphocyte Ratio
The ratio between the neutrophil count and lymphocyte count derived from a complete blood count measurement performed in routine care and captured in the Ontario Laboratory Information System. This measures is typically collected every 4-6 weeks as part of standard dialysis care in Ontario.
Time frame: From randomization to the end of treatment (average 2.9 year follow-up)
Blood Hemoglobin Concentration
Hemoglobin concentration from a complete blood count measurement performed in routine care and captured in the Ontario Laboratory Information System. This measures is typically collected every 4-6 weeks as part of standard dialysis care in Ontario.
Time frame: From randomization to end of treatment (average 2.9 years follow-up)
Serum Albumin Concentration
Serum albumin concentration measured in routine care and captured in the Ontario Laboratory Information System. This measures is typically collected every 4-6 weeks as part of standard dialysis care in Ontario.
Time frame: From randomization to the end of treatment (average 2.9 year follow-up)
Erythropoietin Stimulating Agent (ESA) Utilization
ESAs include darbepoetin or epoetin. Doses will be expressed as the dose per week. Dose will be converted to the weekly total epoetin dose and expressed as units per week. Subcutaneous and intravenous dosing will be considered equivalent. Data will be obtained from local medical record review and reported approximately every 6 months. Participation in reporting of this outcome is optional for sites and will only be assessed in a subset of participating sites.
Time frame: From randomization to end of treatment (average 2.9 years follow-up)
Not enrolling at this site.
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Apr 2031, 68 months after the start.
Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 68 months is above that.
Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's →