DIALysis With EXpanded Solute Removal

NCT ID: NCT06660277

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-12
• Study Completion Date: 2030-08-31

Brief 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).

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; Kidney Failure, Chronic; Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Expanded Hemodialysis

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

Group Type: EXPERIMENTAL

Super High-Flux Dialyzer

Intervention Type: DEVICE

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.

Conventional Hemodialysis

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

Group Type: ACTIVE_COMPARATOR

High-Flux Dialyzer

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

High-Flux Dialyzer

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

Intervention Type: DEVICE

Other Intervention Names

Expanded Hemodialysis; Nipro Elisio HX; Sharp Cut-Off Dialyzer; Medium Cut-Off Dialyzer; Conventional Hemodialysis

Eligibility Criteria

Inclusion Criteria

1. One of:

1. Age 60 years or older; or

2. Age 45 to 59 years with a history of diabetes mellitus (Type 1 or Type 2) regardless of current glycemic status; and

2. Receiving any form of dialysis regularly for the previous 90 days; and

3. Currently receiving HD in-centre (main or satellite unit) 3 or more times per week; and

4. A valid provincial or territorial health insurance card number.

Exclusion Criteria

1. Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to any of:

1. Known or anticipated intolerance to the Nipro Elisio HX dialyzer; or

2. Planned to receive HDF; or

3. Planned to receive nocturnal HD; or

4. 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

5. Anticipated severe non-adherence to the frequency or duration of prescribed dialysis treatment; or

6. An overriding clinical preference for expanded HD (i.e., dialysis with the Elisio HX or other comparable dialyzer, such as Baxter TheranovaTM); or

7. Another medical, psychosocial, or logistical reason; or

2. 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

3. Previously enrolled in this trial; or

4. Declined participation.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schulich School of Medicine and Dentistry

UNKNOWN

Sponsor Role: collaborator

ICES

INDUSTRY

Sponsor Role: collaborator

Nipro Canada Corporation

UNKNOWN

Sponsor Role: collaborator

London Health Sciences Centre

OTHER

Sponsor Role: collaborator

Statistics Canada

UNKNOWN

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pavel S Roshanov, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute

Amit X Garg, MD PhD FRCPC FACP

Role: STUDY_CHAIR

London Health Sciences Centre Research Institute

Locations

London Health Sciences Centre

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Pavel S Roshanov, MD MSc FRCPC

Role: CONTACT

pavel.roshanov@lhsc.on.ca

519-663-3350

Central Research Coordinator

Role: CONTACT

fixdialysis@lhsc.on.ca

Facility Contacts

Pavel S Roshanov, MD MSc FRCPC

Role: primary

pavel.roshanov@lhsc.on.ca

519-663-3350

Central Research Coordinator

Role: backup

fixdialysis@lhsc.on.ca

Other Identifiers

R-25-209

Identifier Type: OTHER

Identifier Source: secondary_id

4954

Identifier Type: -

Identifier Source: org_study_id