Actively Recruiting

Phase Not Applicable
Age: 45Years +
All Genders
NCT06660277

DIALysis With EXpanded Solute Removal

Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2025-08-28

4800

Participants Needed

1

Research Sites

259 weeks

Total Duration

On this page

Sponsors

L

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

Lead Sponsor

S

Schulich School of Medicine and Dentistry

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

DIALysis With EXpanded Solute Removal

Who Can Participate

Age: 45Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 60 years or older, or age 45 to 59 years with a history of diabetes mellitus (Type 1 or Type 2)
  • Receiving any form of dialysis regularly for the previous 90 days
  • Currently receiving in-center hemodialysis 3 or more times per week
  • Have a valid provincial or territorial health insurance card number
Not Eligible

You will not qualify if you...

  • Not appropriate for the study as judged by treating nephrologist or dialysis nurse practitioner due to any of:
    • Known or expected intolerance to the Nipro Elisio HX dialyzer
    • Planned to receive hemodiafiltration (HDF)
    • Planned to receive nocturnal hemodialysis
    • Expected to stop in-center hemodialysis in the next 3 months for reasons such as palliation, transplantation, home dialysis, recovery of kidney function, or death
    • Expected severe non-adherence to prescribed dialysis frequency or duration
    • A strong clinical preference for expanded hemodialysis use
    • Other medical, psychosocial, or logistical reasons
  • Enrolled in another clinical trial that prohibits concurrent participation or interferes with adherence to DIALEX procedures
  • Previously enrolled in this trial
  • Declined participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

London Health Sciences Centre

London, Ontario, Canada, N6A 5W9

Actively Recruiting

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Research Team

P

Pavel S Roshanov, MD MSc FRCPC

CONTACT

C

Central Research Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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