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DIALysis With EXpanded Solute Removal

Study acronym: DIALEX
StatusRecruiting
PhaseNot applicable
Started2025-08-12
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Aug 2030 → Apr 2031
See other at-risk trials from London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Amendment history

2026-09-25
Primary completion pushed: 2030-08 → 2031-04
Completion pushed: 2030-08 → 2031-04
2025-08-22
Not Yet Recruiting→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2030-01→2030-08
Completion date2030-01→2030-08
Start dateestimated 2025-01→confirmed 2025-08-12
Lead sponsorWestern University, Canada→London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Eligibility criteria+588 characters
Inclusion Criteria: Inclusion requires that all the following are present: One of: Age 60 years or older,; or age Age 45 to 59 years andwith usinga medicationhistory to treatof diabetes mellitus (Type 1 or Type 2) regardless of current glycemic status; and Receiving any form of dialysis regularly for the previous 390 monthsdays; and Currently receiving hemodialysisHD in-centre (main or satellite unit) 3 or more times per week; and A valid provincial or territorial health insurance card number. Exclusion Criteria: Patients are ineligible if they meet a [...] n or anticipated intolerance to the Nipro E [...]
Secondary endpoints3 to 6 entries
Death from Cardiovascular Cause Death from Non-cardiovascular Cause Receipt of a Functional Kidney Transplant
Study sitesdetails revised at 1 of 1 site
Collaborators5 entries, revised
PopulationStatistics Health Research InstituteCanada
Study titlerevised
DIALysis withWith EXpanded Solute Removal
2024-11-21
Study Identification, Study Status, Sponsor/Collaborators, Conditions, Study Design, Outcome Measures, Contacts/Locations v1
Study sitescontacts updated at 1 of 1 site
Collaborators7 to 5 entries
Statistics Canada Canadian Institute for Health Information London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study titlerevised
DialysisDIALysis with ExpandedEXpanded Solute Removal
2024-10-23
Original filing
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).
Trial Details
NCT Number NCT06660277
Lead Sponsor London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborators: Schulich School of Medicine and Dentistry, ICES, Nipro Canada Corporation, London Health Sciences Centre, Statistics Canada
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
Enrollment 4,800 participants
Start Date 2025-08-12
Primary Completion 2031-04 (estimated)
Study Completion 2031-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-24