Expanded Hemodialysis for Chronic Kidney Disease
(DIALEX Trial)

Recruiting in Palo Alto (17 mi)

Overseen byPavel S Roshanov, MD MSc FRCPC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Western University, Canada

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for patients with kidney disease, including those with chronic or renal disease, who are already receiving hemodialysis. Participants must be eligible to receive either the super high-flux or conventional high-flux dialyzer treatments.

Inclusion Criteria

I have been on dialysis for the last 3 months.

I am 60 or older, or between 45 and 59 and take diabetes medication.

I am undergoing hemodialysis at a center 3 times a week.

Exclusion Criteria

Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to known or anticipated intolerance to the Nipro Elisio HX dialyzer

My doctor thinks I shouldn't join because I will have overnight dialysis.

Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to anticipated severe non-adherence to the frequency or duration of prescribed dialysis treatment

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Treatment Details

Interventions

High-Flux Dialyzer (Device)
Super High-Flux Dialyzer (Device)

Trial OverviewThe study is testing whether expanded hemodialysis using a super high-flux dialyzer can reduce death risk compared to standard treatment with a conventional high-flux dialyzer. Patients will continue their regular hemodialysis schedule without additional tests.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Expanded HemodialysisExperimental Treatment1 Intervention

Participants will receive their regularly scheduled hemodialysis treatments using a super high-flux dialyzer (Nipro Elisio HX).

Group II: Conventional HemodialysisActive Control1 Intervention

Participants will receive their regularly scheduled hemodialysis treatments using a high-flux dialyzer (as prescribed in routine care).