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

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

This trial will test whether using super high‑flux (expanded) dialysis filters instead of standard high‑flux filters reduces the risk of death and other harms for adults on in‑center hemodialysis who are older or have diabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 4800 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Academic / other)
• Locations: 1 site (London, Ontario)
• Trial ID: NCT06660277 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults receiving in‑center hemodialysis at least three times per week who are age 60 or older, or age 45–59 with diabetes, and who have been on regular dialysis for at least 90 days.

Not a fit: Patients planned for home dialysis, hemodiafiltration (HDF), nocturnal dialysis, those expected to stop in‑center HD soon (for example due to transplant or planned modality change), or with known intolerance to the Nipro Elisio HX dialyzer are unlikely to be eligible and unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, expanded hemodialysis could lower mortality and improve long‑term outcomes for people on in‑center hemodialysis.

How similar studies have performed: Smaller randomized trials and large observational studies have shown promising surrogate and outcome signals for expanded hemodialysis, but no large randomized trial has yet demonstrated a definitive mortality benefit.

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.

Where this trial is running

London, Ontario

• London Health Sciences Centre — London, Ontario, Canada (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

Conditions Chronic Kidney Disease Requiring Hemodialysis; End-Stage Kidney Disease; Chronic Kidney Disease Requiring Chronic Dialysis; Pragmatic Randomized Controlled Trial; Kidney Disease; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Hemodialysis