Expanded Hemodialysis for Chronic Kidney Disease

(DIALEX Trial)

Overseen By Central Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Intolerance to dialyzer, Hemodiafiltration, Nocturnal hemodialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2.9 years

4800 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications, but it mentions that all other aspects of treatments remain the same. It seems likely that you can continue your current medications.

What data supports the effectiveness of the treatment High-Flux Dialyzer and Super High-Flux Dialyzer for chronic kidney disease?

Research shows that high-flux hemodialysis, which uses high-flux dialyzers, can improve survival in high-risk patients with chronic kidney disease by removing more toxins from the blood compared to low-flux hemodialysis. Super high-flux dialyzers, when combined with other techniques, may also enhance toxin removal, potentially offering additional benefits. ^{1 2 3 4 5}

Is expanded hemodialysis using high-flux or super high-flux dialyzers safe for humans?

High-flux and super high-flux dialyzers have been shown to be safe for humans, with studies indicating they effectively remove toxins and are compatible with the blood, minimizing unwanted reactions during treatment. ^{4 5 6 7 8}

How does expanded hemodialysis with high-flux and super high-flux dialyzers differ from other treatments for chronic kidney disease?

Expanded hemodialysis using high-flux and super high-flux dialyzers is unique because it enhances the removal of a wider range of toxins from the blood, including larger molecules that are not easily removed by traditional methods. This is achieved through improved filtration and backfiltration processes, which increase the convective transport of solutes, potentially leading to better patient outcomes. ^{5 6 9 10 11}

What is the purpose of this trial?

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.

Research Team

Pavel S Roshanov, MD MSc FRCPC

Principal Investigator

Western University

Amit X Garg, MD PhD FRCPC FACP

Principal Investigator

London Health Sciences Centre

Eligibility Criteria

This trial is for patients with kidney disease, including those with chronic or renal disease, who are already receiving hemodialysis. Participants must be eligible to receive either the super high-flux or conventional high-flux dialyzer treatments.

Inclusion Criteria

I have been on dialysis for the last 3 months.

I am 60 or older, or between 45 and 59 and take diabetes medication.

I am undergoing hemodialysis at a center 3 times a week.

Exclusion Criteria

Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to known or anticipated intolerance to the Nipro Elisio HX dialyzer

My doctor thinks I shouldn't join because I will have overnight dialysis.

Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to anticipated severe non-adherence to the frequency or duration of prescribed dialysis treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive their regularly scheduled hemodialysis treatments using either a super high-flux/expanded dialysis filter or a high-flux/conventional dialysis filter

2.9 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• High-Flux Dialyzer
• Super High-Flux Dialyzer

Trial Overview The study is testing whether expanded hemodialysis using a super high-flux dialyzer can reduce death risk compared to standard treatment with a conventional high-flux dialyzer. Patients will continue their regular hemodialysis schedule without additional tests.

Participant Groups

Group I: Expanded Hemodialysis Experimental Treatment 1 Intervention

Participants will receive their regularly scheduled hemodialysis treatments using a super high-flux dialyzer (Nipro Elisio HX).

Group II: Conventional Hemodialysis Active Control 1 Intervention

Participants will receive their regularly scheduled hemodialysis treatments using a high-flux dialyzer (as prescribed in routine care).

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Population Health Research Institute

Collaborator

Trials

165

Recruited

717,000+

Canadian Institute for Health Information

Collaborator

Trials

2

Recruited

6,300+

Nipro Canada Corporation

Collaborator

Trials

1

Recruited

4,800+

Schulich School of Medicine and Dentistry

Collaborator

Trials

3

Recruited

4,800+

ICES

Industry Sponsor

Trials

6

Recruited

534,000+

Statistics Canada

Collaborator

Trials

2

Recruited

109,000+

Lawson Health Research Institute

Collaborator

Trials

684

Recruited

432,000+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+

Findings from Research

In a study of 194 patients with End-Stage Renal Disease (ESRD), 14% experienced mortality within 72 hours of admission, highlighting the serious risks associated with advanced uremia and acidemia.

The most common adverse events included hypotension requiring inotropic support (20.6%) and seizures (16%), indicating that early intervention and referral for ESRD patients can significantly reduce morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of End-Stage Renal Disease Patients with Advanced Uremia and Acidemia. Rehman, IU., Idrees, MK., Shoukat, .[2017]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Hemodiafiltration - state of the art. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Recent trials on hemodiafiltration. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

Clinical use of high-efficiency hemodialysis treatments: long-term assessment. [2006]

4. England pubmed.ncbi.nlm.nih.gov

Clinical outcomes for maintenance hemodialysis patients using a high-flux (FX60) dialyzer. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Comparative efficacy between hemodialysis using super high-flux dialyzer with hemoperfusion and high-volume postdilution online hemodiafiltration in removing protein bound and middle molecule uremic toxins: A cross-over randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Performance and Hemocompatibility of a Novel Polysulfone Dialyzer: A Randomized Controlled Trial. [2023]

7. Pakistan pubmed.ncbi.nlm.nih.gov

Outcome of End-Stage Renal Disease Patients with Advanced Uremia and Acidemia. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Improved outcome for haemodialysis patients treated with high-flux membranes. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Mass transfer mechanisms in high-performance membrane dialyzers. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Hemodiafiltration: clinical evidence and remaining questions. [2010]

11. United States pubmed.ncbi.nlm.nih.gov

Enhancement of convective transport by internal filtration in a modified experimental hemodialyzer: technical note. [2004]