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NCT06660277From ClinicalTrials.govRecruiting

DIALysis With EXpanded Solute Removal

DIALysis With EXpanded Solute Removal (DIALEX): A Large, Simple Randomized Trial to Evaluate the Major Health Effects of Expanded Versus Conventional Hemodialysis.

  • Chronic Kidney Disease Requiring Hemodialysis
  • End-Stage Kidney Disease (ESKD)
  • Chronic Kidney Disease Requiring Chronic Dialysis
  • Pragmatic Randomized Controlled Trial
  • Kidney Disease
  • Renal Insufficiency, Chronic
  • Kidney Failure, Chronic
  • Hemodialysis

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Enrolment target
4,800
Started
12 August 2025
Main results due
April 2031
Study sites
3
Registry updated
24 September 2026

Can you take part?

  • Aged 45 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(3)

  • London Health Sciences Centre

    London, Ontario, Canada

    Recruiting

  • Orillia Soldiers' Memorial Hospital

    Orillia, Ontario, Canada

    Recruiting

  • The Ottawa Hospital

    Ottawa, Ontario, Canada

    Active, not recruiting

Showing 3 of 3 sites. 2 of the 3 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06660277. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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DIALysis With EXpanded Solute Removal | Trialion