RecruitingNot ApplicableNCT06660277

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.


Sponsor

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

Enrollment

4,800 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This trial compares standard hemodialysis with an expanded hemodialysis approach using a special filter to see if removing more toxins from the blood improves health outcomes in people on regular dialysis. **You may be eligible if...** - You are 60 years or older, OR between 45–59 years old with diabetes - You have been on any form of dialysis for at least 90 days - You currently receive in-center hemodialysis 3 or more times per week - You have a valid provincial or territorial health insurance card **You may NOT be eligible if...** - Your doctor does not feel the study is appropriate for you - You are planned to switch from in-center HD within the next 3 months - You have a strong clinical preference for the expanded HD approach already - You are enrolled in another trial that prohibits dual participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESuper 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.

DEVICEHigh-Flux Dialyzer

A hemodialysis filter (known as a dialyzer) that is that is widely used across Canada for hemodialysis treatments.


Locations(1)

London Health Sciences Centre

London, Ontario, Canada

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NCT06660277


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