Clinical trial NCT06660277: DIALysis with EXpanded Solute Removal
Official title: DIALysis with EXpanded Solute Removal (DIALEX): a Large, Simple Randomized Trial to Evaluate the Major Health Effects of Expanded Versus Conventional Hemodialysis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Kidney Disease Requiring Hemodialysis
End-Stage Kidney Disease (ESKD)
Keywords: dialyzer
expanded hemodialysis
filter
Nipro Elisio HX
randomized
RCT
pragmatic
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Schulich School of Medicine and Dentistry
name: ICES
name: Population Health Research Institute
name: Nipro Canada Corporation
name: London Health Sciences Centre
First posted: 2024-10-28
Enrollment: 4800
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in a 1:3 or 1:1 (Expanded HD : Conventional High-Flux HD) ratio, depending on their study site.
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: Inclusion Criteria: Inclusion requires that all the following are present:

1. Age 60 years or older, or age 45 to 59 years and using medication to treat diabetes;
2. Receiving any form of dialysis regularly for the previous 3 months; and
3. Currently receiving hemodialysis in-centre (main or satellite unit) 3 or more times per week.

Exclusion Criteria: Patients are ineligible if they meet any of the following criteria:

1. Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to any of:

   1. Known or anticipated intolerance to the Nipro Elisio HX dialyzer
   2. Planned to receive hemodiafiltration
   3. Planned to receive nocturnal hemodialysis
   4. Anticipated to discontinue in-centre hemodialysis in the next 3 months for any reason (examples: palliation, transplantation, home dialysis, recovery of kidney function, death, others)
   5. Anticipated severe non-adherence to the frequency or duration of prescribed dialysis treatment
2. Previously enrolled in this trial
3. Declined participation

Primary outcomes:
measure: Primary Outcome of All-Cause Mortality
timeFrame: From enrollment to event (death) or end of treatment (average 2.9 years), whichever occurs first
Secondary outcomes:
measure: Key Secondary Outcome of Cardiovascular and Infection-Related Hospitalizations
timeFrame: From enrollment to end of treatment (average 2.9 years)
measure: Cardiovascular-Related Hospitalizations
timeFrame: From enrollment to end of treatment (average 2.9 years)
measure: Infection-Related Hospitalizations
timeFrame: From enrollment to end of treatment (average 2.9 years)
Other outcomes:
measure: Healthcare-Associated Costs
timeFrame: From enrollment to end of treatment (average 2.9 years)
measure: Patient Reported Symptoms
timeFrame: From enrollment to end of treatment (average 2.9 years)
measure: Effects on Inflammation - Neutrophil to Lymphocyte Ratio
timeFrame: From enrollment to end of treatment (average 2.9 years)
measure: Effects on Inflammation - C-reactive Protein
timeFrame: From enrollment to end of treatment (average 2.9 years)
measure: Effects on Inflammation - Serum Albumin
timeFrame: From enrollment to end of treatment (average 2.9 years)
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University
name: Pavel S Roshanov, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: London Health Sciences Centre
name: Amit X Garg, MD PhD FRCPC FACP
role: STUDY_CHAIR
References: