NCT06660277

DIALysis With EXpanded Solute Removal

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,800 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Background: Expanded hemodialysis refers to hemodialysis treatment using a newer generation of hemodialysis filters or "dialyzers" that remove large middle molecules to a greater extent than conventional "high-flux" dialyzers. This is expected to improve major health outcomes. However, despite a decade of availability and promising surrogate data from small trials and patient outcomes data from large observational studies, dialyzers capable of providing expanded hemodialysis have failed to achieve significant adoption conventional high-flux dialyzers in the absence of more definitive evidence. A large, rigorous randomized controlled trial is necessary to establish the clinical effectiveness of expanded hemodialysis compared to conventional hemodialysis with high-flux dialyzers. Study Design: Parallel, block randomized, controlled, open label, superiority trial comparing the clinical effects of expanded hemodialysis using Nipro Elisio HX dialyzers to conventional hemodialysis using high-flux dialyzers. The allocation ratio will vary between 1:3 or 1:1 ratio depending on their dialysis unit. Setting: Community and academic hemodialysis facilities. Study Size: 4800 participants (1200 in expanded hemodialysis arm and 3600 in conventional high-flux hemodialysis arm) followed for a mean of 2.9 years. Trial Duration: Duration of participant accrual - 2 years from date of first participant recruited. Total duration - 5 years from date of first participant recruited. Trial results anticipated to be announced in 2030. Study Power: 90% power to detect 15% relative reduction in the hazard of death (hazard ratio 0.85).

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

Interventions

Type	Name	Description
DEVICE	Super High-Flux Dialyzer	A hemodialysis filter (known as a dialyzer) that is currently approved by Health Canada and available for use across Canada. This filter has larger pores than a high-flux dialyzer that allow for greater removal of potential toxins and wastes in the blood that would regularly be filtered out by healthy kidneys.
DEVICE	High-Flux Dialyzer	A hemodialysis filter (known as a dialyzer) that is that is widely used across Canada for hemodialysis treatments.

Timeline

• Start date: 2025-08-12
• Primary completion: 2030-08-01
• Completion: 2030-08-01
• First posted: 2024-10-28
• Last updated: 2025-08-28

Locations

1 site across 1 country: Canada