DIALysis With EXpanded Solute Removal

NCT06660277 | Recruiting DMC

• 2 other identifiers: 4954R-25-209
• Study Type: interventional
• Target: 4,800
• Locations: 1 country
• Sites: 1

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).

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

Keywords

Nipro Elisio HX; RCT; Dialyzer; Hemodialysis Filter; Super-High Flux Dialyzer; High-Flux Dialyzer; Expanded Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From randomization to the end of treatment (average 2.9 year follow-up)

• Cardiovascular-Related Hospitalizations

  From randomization to the end of treatment (average 2.9 year follow-up)

• Infection-Related Hospitalizations

  From randomization to the end of treatment (average 2.9 year follow-up)

• Death from Cardiovascular Cause

  From randomization to end of treatment (average 2.9 year follow-up).

• Death from Non-cardiovascular Cause

  From randomization to end of treatment (average 2.9 year follow-up).

Other Outcomes (6)

• Routine Care Symptoms

  From randomization to the end of treatment (average 2.9 year follow-up)

• Healthcare-Associated Costs

  From randomization to the end of treatment (average 2.9 year follow-up)

• Neutrophil to Lymphocyte Ratio

  From randomization to the end of treatment (average 2.9 year follow-up)

Study Arms (2)

Expanded Hemodialysis

EXPERIMENTAL

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

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).

Device: High-Flux Dialyzer

Interventions

Super High-Flux Dialyzer 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.

Also known as: Expanded Hemodialysis, Nipro Elisio HX, Sharp Cut-Off Dialyzer, Medium Cut-Off Dialyzer

Expanded Hemodialysis

High-Flux Dialyzer DEVICE

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

Also known as: Conventional Hemodialysis

Conventional Hemodialysis

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Schulich School of Medicine and Dentistry: collaborator
• ICES: collaborator
• Nipro Canada Corporation: collaborator
• London Health Sciences Centre: collaborator
• Statistics Canada: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Kidney Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pavel S Roshanov, MD MSc FRCPC

  London Health Sciences Centre Research Institute

  PRINCIPAL INVESTIGATOR

• Amit X Garg, MD PhD FRCPC FACP

  London Health Sciences Centre Research Institute

  STUDY CHAIR

Central Study Contacts

Pavel S Roshanov, MD MSc FRCPC

CONTACT

519-663-3350; pavel.roshanov@lhsc.on.ca

Central Research Coordinator

CONTACT

fixdialysis@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in a 1:3 or 1:1 (Expanded HD : Conventional High-Flux HD) ratio, depending on their study site.

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 28, 2024
• Study Start: August 12, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)