DIALysis With EXpanded Solute Removal (DIALEX): A Large, Simple Randomized Trial to Evaluate the Major Health Effects of Expanded Versus Conventional Hemodialysis.
Pavel RoshanovActively Recruiting
About This Study
DIALEX is a pragmatic, open-label, randomized superiority trial evaluating the clinical efficacy of expanded hemodialysis compared to conventional high-flux hemodialysis in patients with ESKD. The study enrolls 4,800 participants across community and academic facilities to determine if the use of super high-flux dialyzers, which enhance the removal of large middle molecules, reduces all-cause mortality. Participants are randomized to receive either expanded hemodialysis using Nipro Elisio HX dialyzers or standard care with conventional high-flux filters during their regularly scheduled treatments. Researchers utilize administrative healthcare databases and medical record reviews to track longitudinal outcomes over a mean follow-up period of 2.9 years. The trial is powered to detect a 15% relative reduction in the hazard of death.
Who Can Participate?
✓ Inclusion Criteria
- •Age 60 years or older; or Age 45 to 59 years with a history of diabetes mellitus (Type 1 or Type 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.
✗ Exclusion Criteria
- •Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to any of:
- •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
- •Anticipated severe non-adherence to the frequency or duration of prescribed dialysis treatment; or
- •An overriding clinical preference for expanded HD (i.e.,dialysis with the Elisio HX or other comparable dialyzer such as Baxter TheranovaTM); or
- •Another medical, psychosocial. or logistical reason; or
- •Enrolled in another clinical trial that explicitly prohibits concurrent participation in other clinical trials or that would substantially interfere with adherence to the DIALEX procedures (note that DIALEX otherwise permits concurrent participation in other trials); or
- •Previously enrolled in this trial; or
- •Declined participation.