Comparing Super High-Flux Dialyzer with High-Flux Dialyzer for chronic kidney disease requiring hemodialysis
Official title: 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.
- 2 groups
- One site, in London
- Recruiting
Interventions
- Medical device
Super 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.
- Medical device
High-Flux Dialyzer
A hemodialysis filter (known as a dialyzer) that is that is widely used across Canada for hemodialysis treatments.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario
Eligibility Criteria
See who this study is looking for18 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age 45 to 59 years with a history of diabetes mellitus (Type 1 or Type 2) regardless of current glycemic status; and
- +InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → requires that all the following are present:
- +Age 60 years or older; or
- +Receiving any form of dialysis regularly for the previous 90 days; and
- +Currently receiving HD in-centre (main or satellite unit) 3 or more times per week; and
- +A valid provincial or territorial health insurance card number.
Exclusion
- −Patients are ineligible if they meet any of the following criteria:
- −Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to any of:
- −Known or anticipated intolerance to the Nipro Elisio HX dialyzer; or
- −Planned to receive HDF; or
- −Planned to receive nocturnal HD; or
- −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
- −Anticipated severe non-adherence to the frequency or duration of prescribed dialysis treatment; or
- −An overriding clinical preference for expanded HD (i.e., dialysis with the Elisio HX or other comparable dialyzer, such as Baxter TheranovaTM); or
- −Another medical, psychosocial, or logistical reason; or
- −EnrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in another clinical trialInterventional studyA study where participants are given something to see what happens.Read more → 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
- −Previously enrolled in this trial; or
- −Declined participation.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Super High-Flux Dialyzer.
Registry label: A: Expanded Hemodialysis
Group B, the comparison group, receives High-Flux Dialyzer.
Registry label: B: Conventional Hemodialysis
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 45 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 4,800 people.
The study is currently expected to finish around August 2030.
The main measurement is taken over: From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to event (death) or end of treatment (average 2.9 years follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →), whichever occurs first.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Primary OutcomePrimary endpointThe single main question the study is designed to answer.Read more → of All-Cause Mortality — measured over From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to event (death) or end of treatment (average 2.9 years follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →), whichever occurs first.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06660277 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Super High-Flux DialyzerDevice
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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
About High-Flux DialyzerDevice
A hemodialysis filter (known as a dialyzer) that is that is widely used across Canada for hemodialysis treatments.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 45 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 45 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: From randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to event (death) or end of treatment (average 2.9 years follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →), whichever occurs first.
The study as a whole is currently expected to finish around 2030-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 4,800 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: London, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About 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 and medical record review (at a subset of participating locations).
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.