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Expanded Hemodialysis for Chronic Kidney Disease (DIALEX Trial)

N/A
Waitlist Available
Led By Pavel S Roshanov, MD MSc FRCPC
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving any form of dialysis regularly for the previous 3 months
Currently receiving hemodialysis in-centre (main or satellite unit) 3 or more times per week
Must not have
Declined participation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to end of treatment (average 2.9 years)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if a new type of hemodialysis, called expanded hemodialysis, is better at improving patient outcomes and reducing the risk of death compared to conventional hemodialysis. Participants

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Since participants will continue their usual hemodialysis but with different filters, side effects may not significantly differ from their current experiences. However, specific side effects of the new filter aren't detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on dialysis for the last 3 months.
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I am undergoing hemodialysis at a center 3 times a week.
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I am 60 or older, or between 45 and 59 and take diabetes medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have chosen not to participate in this trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to end of treatment (average 2.9 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to end of treatment (average 2.9 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
of All-Cause Mortality
Secondary study objectives
Cardiovascular-Related Hospitalizations
Infection-Related Hospitalizations
Key of Cardiovascular and Infection-Related Hospitalizations
Other study objectives
Effects on Inflammation - C-reactive Protein
Effects on Inflammation - Neutrophil to Lymphocyte Ratio
Effects on Inflammation - Serum Albumin
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

Find a Location

Who is running the clinical trial?

Population Health Research InstituteOTHER
164 Previous Clinical Trials
713,714 Total Patients Enrolled
Canadian Institute for Health InformationOTHER
1 Previous Clinical Trials
1,538 Total Patients Enrolled
Nipro Canada CorporationUNKNOWN
~3200 spots leftby Jan 2030