DIALysis With EXpanded Solute Removal (DIALEX): A Large, Simple Randomized Trial to Evaluate the Major Health Effects of Expanded Versus Conventional Hemodialysis.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
London Health Sciences Centre
RECRUITING
London
Contact Information
Primary
Pavel S Roshanov, MD MSc FRCPC
pavel.roshanov@lhsc.on.ca
519-663-3350
Backup
Central Research Coordinator
fixdialysis@lhsc.on.ca
Time Frame
Start Date: 2025-08-12
Estimated Completion Date: 2030-08
Participants
Target number of participants: 4800
Treatments
Experimental: Expanded Hemodialysis
Participants will receive their regularly scheduled hemodialysis treatments using a super high-flux dialyzer (Nipro Elisio HX).
Active_comparator: Conventional Hemodialysis
Participants will receive their regularly scheduled hemodialysis treatments using a high-flux dialyzer (as prescribed in routine care).
Related Therapeutic Areas
Sponsors
Collaborators: Schulich School of Medicine and Dentistry, Statistics Canada, ICES, London Health Sciences Centre, Nipro Canada Corporation
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov