DIALysis With EXpanded Solute Removal

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Super High-Flux Dialyzer
  • High-Flux Dialyzer

Treatment groups

4,800 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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

Lead sponsor

Schulich School of Medicine and Dentistry

Collaborator

ICES

Collaborator

Nipro Canada Corporation

Collaborator

London Health Sciences Centre

Collaborator

Statistics Canada

Collaborator