Actively Recruiting
DIALysis With EXpanded Solute Removal (DIALEX): A Large, Simple Randomized Trial to Evaluate the Major Health Effects of Expanded Versus Conventional Hemodialysis.
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
N/A
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
This research aims to evaluate the health effects of expanded hemodialysis compared to conventional hemodialysis in patients receiving regular hemodialysis treatment. The main goal is to determine whether expanded hemodialysis lowers the risk of death from any cause. The trial is a large, randomized controlled study involving 4,800 participants followed for an average of 2.9 years, with results expected in 2030. Participants will receive their usual hemodialysis treatments using either a super high-flux dialyzer (Nipro Elisio HX) that removes larger molecules more effectively or a conventional high-flux dialyzer used in standard care. The study is open label and randomly assigns participants to either the expanded or conventional hemodialysis group. Treatments continue as usual without additional visits or tests. During the study, data will be collected through healthcare records and medical record reviews at some locations. Researchers will monitor outcomes such as all-cause mortality, cardiovascular and infection-related hospitalizations, and kidney transplant events over the study period. The total study duration includes participant accrual over two years with a mean follow-up near three years.
CONDITIONS
Brief Title
DIALysis With EXpanded Solute Removal
Who Can Participate
Eligibility Criteria
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
You will not qualify if you...
- Not appropriate for the study due to intolerance to the Nipro Elisio HX dialyzer
- Planned to receive hemodiafiltration (HDF) or nocturnal hemodialysis
- Expected to stop in-center hemodialysis within 3 months (due to palliation, transplantation, home dialysis, recovery, death, etc.)
- Expected severe non-adherence to prescribed dialysis frequency or duration
- Strong clinical preference for expanded hemodialysis dialyzer
- Another medical, psychosocial, or logistical reason
- Enrolled in another clinical trial that prohibits concurrent participation or interferes with adherence
- Previously enrolled in this trial
- Declined participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Average of 2.9 years
Participants receive their regularly scheduled hemodialysis treatments using either a super high-flux dialyzer or a high-flux dialyzer as prescribed.
3 or more hemodialysis sessions per week
Trial Site Locations
Total: 1 location
1
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
Research Team
P
Pavel S Roshanov, MD MSc FRCPC
C
Central Research Coordinator
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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