Recruiting

Expanded Hemodialysis

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT06660277

Conditions

Chronic Kidney Disease Requiring Hemodialysis

End-Stage Kidney Disease (ESKD)

Chronic Kidney Disease Requiring Chronic Dialysis

Pragmatic Randomized Controlled Trial

Kidney Disease

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Super High-Flux Dialyzer

High-Flux Dialyzer

Study Details

Brief 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).

Conditions

Chronic Kidney Disease Requiring Hemodialysis

End-Stage Kidney Disease (ESKD)

Chronic Kidney Disease Requiring Chronic Dialysis

Pragmatic Randomized Controlled Trial

Kidney Disease

Study ID

NCT06660277

Start date

Aug 12, 2025

Status verified date

Sep, 2026

Completion date

Apr, 2031

Anticipated

Primary completion date

Apr, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

4800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Expanded Hemodialysis

Participants will receive their regularly scheduled hemodialysis treatments using a super high-flux dialyzer (Nipro Elisio HX).

active comparator: Conventional Hemodialysis

Participants will receive their regularly scheduled hemodialysis treatments using a high-flux dialyzer (as prescribed in routine care).

Interventions

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.

Primary outcome measure

  • Primary Outcome of All-Cause Mortality [ Time Frame: From randomization to event (death) or end of treatment (average 2.9 years follow-up), whichever occurs first ]

Central Contacts and Locations

Central contacts

Pavel S Roshanov, MD MSc FRCPC

519-663-3350pavel.roshanov@lhsc.on.ca

Central Research Coordinator

fixdialysis@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Pavel S Roshanov, MD MSc FRCPC

519-663-3350pavel.roshanov@lhsc.on.ca

Central Research Coordinator

fixdialysis@lhsc.on.ca

Principal Investigator:

Pavel S Roshanov, MD MSc FRCPC

Orillia Soldiers' Memorial Hospital

Recruiting

Orillia, Ontario, Canada, L3V 3B5

Contacts

Research Coordinator

+1-705-327-9156fixdialysis@lhsc.on.ca

Principal Investigator:

Jason Bau, MD, PhD

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • Nipro Elisio HX
  • RCT
  • Dialyzer
  • Hemodialysis Filter
  • Super-High Flux Dialyzer
  • High-Flux Dialyzer
  • Expanded Hemodialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.