Chronic Kidney Disease Requiring HemodialysisDIALEXNCT06660277
DIALysis With EXpanded Solute Removal
A study testing Super High-Flux Dialyzer and High-Flux Dialyzer in people with Chronic Kidney Disease Requiring Hemodialysis and End-Stage Kidney Disease (ESKD), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 3 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Hemodialysis, End-Stage Kidney Disease (ESKD), Chronic Kidney Disease Requiring Chronic Dialysis
- What is being tested?
- Super High-Flux Dialyzer and High-Flux Dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,800 participants
- Where
- 3 sitesCanada
- Study dates
- 12 Aug 2025to Apr 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Inclusion requires that all the following are present:
- One of:
- Age 60 years or older; or
- Age 45 to 59 years with a history of diabetes mellitus (Type 1 or Type 2) regardless of current glycemic status; and
- 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 Criteria: 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
- 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
- Previously enrolled in this trial; or
- Declined participation.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Central Research Coordinator contact
Canada3 sites, 2 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A 5W9
Pavel S Roshanov, MD MSc FRCPC, 519-663-3350, pavel.roshanov@lhsc.on.ca
Central Research Coordinator, fixdialysis@lhsc.on.ca
- Recruiting
Orillia Soldiers' Memorial Hospital
Orillia, Ontario, L3V 3B5
Research Coordinator, +1-705-327-9156, fixdialysis@lhsc.on.ca
Jason Bau, MD, PhD
- Active, not recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H8L6
About this study
Official title: DIALysis With EXpanded Solute Removal (DIALEX): A Large, Simple Randomized Trial to Evaluate the Major Health Effects of Expanded Versus Conventional Hemodialysis.
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:
- Does expanded hemodialysis reduce the risk of death from any cause?
Read more
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).
Read the detailed description
Background:
Expanded hemodialysis refers to hemodialysis treatment using a newer generation of hemodialysis filters or "dialyzers" that remove large middle molecules to a greater extent than conventional "high-flux" dialyzers. This is expected to improve major health outcomes. However, despite a decade of availability and promising surrogate data from small trials and patient outcomes data from large observational studies, dialyzers capable of providing expanded hemodialysis have failed to achieve significant adoption conventional high-flux dialyzers in the absence of more definitive evidence. A large, rigorous randomized controlled trial is necessary to establish the clinical effectiveness of expanded hemodialysis compared to conventional hemodialysis with high-flux dialyzers.
Study Design:
Parallel, block randomized, controlled, open label, superiority trial comparing the clinical effects of expanded hemodialysis using Nipro Elisio HX dialyzers to conventional hemodialysis using high-flux dialyzers. The allocation ratio will vary between 1:3 or 1:1 ratio depending on their dialysis unit.
Setting:
Community and academic hemodialysis facilities.
Study Size:
4800 participants (1200 in expanded hemodialysis arm and 3600 in conventional high-flux hemodialysis arm) followed for a mean of 2.9 years.
Trial Duration:
Duration of participant accrual - 2 years from date of first participant recruited.
Total duration - 5 years from date of first participant recruited. Trial results anticipated to be announced in 2030.
Study Power:
90% power to detect 15% relative reduction in the hazard of death (hazard ratio 0.85).
- Conditions
- Chronic Kidney Disease Requiring Hemodialysis, End-Stage Kidney Disease (ESKD), Chronic Kidney Disease Requiring Chronic Dialysis, Pragmatic Randomized Controlled Trial, Kidney Disease, Renal Insufficiency, Chronic
- Being tested
- Super High-Flux Dialyzer, High-Flux Dialyzer
- Keywords
- Nipro Elisio HX, RCT, Dialyzer, Hemodialysis Filter, Super-High Flux Dialyzer, High-Flux Dialyzer, Expanded Hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Kidney Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super High-Flux DialyzerDevice
Also called Expanded Hemodialysis, Nipro Elisio HX, Sharp Cut-Off Dialyzer, Medium Cut-Off 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.
High-Flux DialyzerDevice
Also called Conventional Hemodialysis
A hemodialysis filter (known as a dialyzer) that is that is widely used across Canada for hemodialysis treatments.
| Study group | Role | What they receive |
|---|---|---|
| Expanded Hemodialysis | Experimental | Participants will receive their regularly scheduled hemodialysis treatments using a super high-flux dialyzer (Nipro Elisio HX). Receives: Device: Super High-Flux Dialyzer |
| Conventional Hemodialysis | Active comparator | Participants will receive their regularly scheduled hemodialysis treatments using a high-flux dialyzer (as prescribed in routine care). Receives: Device: High-Flux Dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome of All-Cause Mortality
Outcome data will be collected as a result of routine patient interactions with the healthcare system and will be obtained from national and provincial data repositories (with the exceptions of routine care symptoms and ESA utilization outcomes, in participating sites), enabling health records to be analyzed in a privacy-compliant manner. These datasets have high levels of completeness and validity. The primary outcome, all-cause mortality, is captured with over 99% accuracy in our data sources.
Measured: From randomization to event (death) or end of treatment (average 2.9 years follow-up), whichever occurs first
Secondary outcomes (6)
Key Secondary Outcome of Cardiovascular and Infection-Related Hospitalizations
The key secondary outcome will be time to first and recurrent cardiovascular or infection-related hospitalizations. Cardiovascular and infection-related hospitalizations will be ascertained using primary discharge ICD-10 diagnosis codes in the Canadian Institute for Health Information Discharge Abstract Database
Measured: From randomization to the end of treatment (average 2.9 year follow-up)
Cardiovascular-Related Hospitalizations
Time to first and recurrent cardiovascular hospitalizations. Each component of the secondary outcome (cardiovascular-related and infection-related hospitalizations) will be examined separately.
Measured: From randomization to the end of treatment (average 2.9 year follow-up)
Infection-Related Hospitalizations
Time to first and recurrent infection-related hospitalizations. Each component of the secondary outcome (cardiovascular-related and infection-related hospitalizations) will be examined separately.
Measured: From randomization to the end of treatment (average 2.9 year follow-up)
Death from Cardiovascular Cause
Defined as any out-of-hospital death or death that occurred during a hospitalization for a cardiovascular cause captured in Canada in the CIHI-DAD database.
Measured: From randomization to end of treatment (average 2.9 year follow-up).
Death from Non-cardiovascular Cause
Death that does not meet the definition for death from a cardiovascular cause.
Measured: From randomization to end of treatment (average 2.9 year follow-up).
Receipt of a Functional Kidney Transplant
Receipt of a functional kidney transplant is defined, in Canada, by a record of a hospital admission in the CIHI-DAD database with an ICD-10 code for kidney transplantation followed by discontinuation of dialysis in the absence of death. Receipt of a functioning kidney transplant refers to the first functioning transplant received after randomization.
Measured: From randomization to event (functioning kidney transplant) or end of treatment (average 2.9 years follow-up), whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start12 Aug 2025
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Requiring HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:3 or 1:1 (Expanded HD : Conventional High-Flux HD) ratio, depending on their study site.
- Masking
- None (open label)
- Enrolment
- 4,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Schulich School of Medicine and Dentistry, ICES, Nipro Canada Corporation, London Health Sciences Centre, Statistics Canada
- Responsible party
- Sponsor
- Investigators
- Pavel S Roshanov, MD MSc FRCPC, Principal investigator, London Health Sciences Centre Research InstituteAmit X Garg, MD PhD FRCPC FACP, Study chair, London Health Sciences Centre Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660277
- Sponsor's protocol ID
- 4954
- Other IDs
- R-25-209
- Acronym
- DIALEX
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIALysis With EXpanded Solute Removal (DIALEX): A Large, Simple Randomized Trial to Evaluate the Major Health Effects of Expanded Versus Conventional Hemodialysis.
- ClinicalTrials.gov ID
- NCT06660277
- Acronym / sponsor ID
- DIALEX / 4954
- Conditions
- Chronic Kidney Disease Requiring Hemodialysis, End-Stage Kidney Disease (ESKD), Chronic Kidney Disease Requiring Chronic Dialysis, Pragmatic Randomized Controlled Trial, Kidney Disease, Renal Insufficiency, Chronic
- Keywords
- Nipro Elisio HX, RCT, Dialyzer, Hemodialysis Filter, Super-High Flux Dialyzer, High-Flux Dialyzer, Expanded Hemodialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Schulich School of Medicine and Dentistry, ICES, Nipro Canada Corporation, London Health Sciences Centre, Statistics Canada
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
Detailed description
Background:
Expanded hemodialysis refers to hemodialysis treatment using a newer generation of hemodialysis filters or "dialyzers" that remove large middle molecules to a greater extent than conventional "high-flux" dialyzers. This is expected to improve major health outcomes. However, despite a decade of availability and promising surrogate data from small trials and patient outcomes data from large observational studies, dialyzers capable of providing expanded hemodialysis have failed to achieve significant adoption conventional high-flux dialyzers in the absence of more definitive evidence. A large, rigorous randomized controlled trial is necessary to establish the clinical effectiveness of expanded hemodialysis compared to conventional hemodialysis with high-flux dialyzers.
Study Design:
Parallel, block randomized, controlled, open label, superiority trial comparing the clinical effects of expanded hemodialysis using Nipro Elisio HX dialyzers to conventional hemodialysis using high-flux dialyzers. The allocation ratio will vary between 1:3 or 1:1 ratio depending on their dialysis unit.
Setting:
Community and academic hemodialysis facilities.
Study Size:
4800 participants (1200 in expanded hemodialysis arm and 3600 in conventional high-flux hemodialysis arm) followed for a mean of 2.9 years.
Trial Duration:
Duration of participant accrual - 2 years from date of first participant recruited.
Total duration - 5 years from date of first participant recruited. Trial results anticipated to be announced in 2030.
Study Power:
90% power to detect 15% relative reduction in the hazard of death (hazard ratio 0.85).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:3 or 1:1 (Expanded HD : Conventional High-Flux HD) ratio, depending on their study site.
| Arm | Type | Receives |
|---|---|---|
| Expanded Hemodialysis | Experimental | Device: Super High-Flux DialyzerParticipants will receive their regularly scheduled hemodialysis treatments using a super high-flux dialyzer (Nipro Elisio HX). |
| Conventional Hemodialysis | Active comparator | Device: High-Flux DialyzerParticipants will receive their regularly scheduled hemodialysis treatments using a high-flux dialyzer (as prescribed in routine care). |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super High-Flux DialyzerAlso: Expanded Hemodialysis, Nipro Elisio HX, Sharp Cut-Off Dialyzer, Medium Cut-Off DialyzerA 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. | Device | Expanded Hemodialysis |
| High-Flux DialyzerAlso: Conventional HemodialysisA hemodialysis filter (known as a dialyzer) that is that is widely used across Canada for hemodialysis treatments. | Device | Conventional Hemodialysis |
Primary outcome
Primary Outcome of All-Cause Mortality
Time frame: From randomization to event (death) or end of treatment (average 2.9 years follow-up), whichever occurs first
Outcome data will be collected as a result of routine patient interactions with the healthcare system and will be obtained from national and provincial data repositories (with the exceptions of routine care symptoms and ESA utilization outcomes, in participating sites), enabling health records to be analyzed in a privacy-compliant manner. These datasets have high levels of completeness and validity. The primary outcome, all-cause mortality, is captured with over 99% accuracy in our data sources.
6 secondary outcomes
Key Secondary Outcome of Cardiovascular and Infection-Related Hospitalizations
Time frame: From randomization to the end of treatment (average 2.9 year follow-up)
Cardiovascular-Related Hospitalizations
Time frame: From randomization to the end of treatment (average 2.9 year follow-up)
Infection-Related Hospitalizations
Time frame: From randomization to the end of treatment (average 2.9 year follow-up)
Death from Cardiovascular Cause
Time frame: From randomization to end of treatment (average 2.9 year follow-up).
Death from Non-cardiovascular Cause
Time frame: From randomization to end of treatment (average 2.9 year follow-up).
Receipt of a Functional Kidney Transplant
Time frame: From randomization to event (functioning kidney transplant) or end of treatment (average 2.9 years follow-up), whichever comes first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Central Research Coordinator contact
Pavel S Roshanov, MD MSc FRCPC principal investigator
London Health Sciences Centre Research Institute
Amit X Garg, MD PhD FRCPC FACP study chair
London Health Sciences Centre Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super High-Flux Dialyzer and High-Flux Dialyzer in people with Chronic Kidney Disease Requiring Hemodialysis and End-Stage Kidney Disease (ESKD), run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pavel S Roshanov, MD MSc FRCPC (519-663-3350, pavel.roshanov@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome of All-Cause Mortality (time frame: From randomization to event (death) or end of treatment (average 2.9 years follow-up), whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.