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DIALysis With EXpanded Solute Removal

RecruitingNAAges 45 Years - anyAllLondon Health Sciences Centre Research Institute …
NCT06660277 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • Super High-Flux Dialyzer
  • High-Flux Dialyzer
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Where

3 sites
London Health Sciences Centre
London, Canada
Orillia Soldiers' Memorial Hospital
Orillia, Canada
The Ottawa Hospital
Ottawa, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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