Dialysis that removes more middle molecules using super high‑flux filters

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants are randomly assigned to receive either expanded hemodialysis with Nipro Elisio HX super high‑flux dialyzers or conventional high‑flux dialyzers while continuing their usual in‑center HD schedule. The open‑label, block‑randomized, superiority design aims to enroll about 4,800 patients and follow them for an average of 2.9 years, with allocation ratios of 1:3 or 1:1 depending on the dialysis unit. Primary and secondary outcomes, including all‑cause mortality, will be captured using administrative healthcare databases and medical record review at a subset of sites, and no extra visits or procedures are required. The trial is being run across community and academic hemodialysis facilities in Canada and is led by London Health Sciences Centre with academic and industry collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Principal investigator: Pavel S Roshanov, MD MSc FRCPC — London Health Sciences Centre Research Institute
• Study coordinator: Pavel S Roshanov, MD MSc FRCPC
• Email: pavel.roshanov@lhsc.on.ca
• Phone: 519-663-3350

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.