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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine if expanded hemodialysis, which uses a super high-flux dialyzer, can lower the risk of death compared to conventional hemodialysis. The goal is to improve outcomes for individuals who regularly undergo hemodialysis for chronic kidney disease. Participants will maintain their usual dialysis schedule, using either the new expanded hemodialysis filter or the standard one. Suitable candidates have been on regular dialysis for the past 90 days and currently receive in-center hemodialysis at least three times a week. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future dialysis treatments.

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 prior data suggests that expanded hemodialysis is safe for patients with chronic kidney disease?

Research has shown that the super high-flux dialyzer, used in expanded hemodialysis, is generally well-tolerated. Studies have found it effective in removing waste from the blood, with safety comparable to regular methods. In one study, patients using this dialyzer experienced no more side effects than those using traditional high-flux dialyzers. This suggests the treatment is safe for humans, as no major negative effects were reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of expanded hemodialysis because it uses a super high-flux dialyzer, which can filter out more toxins from the blood than standard high-flux dialyzers typically used in conventional hemodialysis. This advanced filtration might lead to better outcomes for patients with chronic kidney disease by more effectively removing waste products that can build up between dialysis sessions. The super high-flux dialyzer could also improve overall treatment efficiency, potentially enhancing patients' quality of life and health outcomes.

What evidence suggests that expanded hemodialysis is effective for chronic kidney disease?

Research has shown that expanded hemodialysis, which participants in this trial may receive using a special filter like the Nipro ELISIO HX, can remove waste from the blood more effectively. These filters clear larger waste products attached to proteins better than regular filters. One study found that this type of hemodialysis performed as well as high-volume hemodiafiltration in removing these waste products. This suggests that expanded hemodialysis might clean the blood more thoroughly, potentially leading to better health outcomes. However, more research is needed to determine if it actually lowers the risk of death. ^{1 2 3 4 6}

Who Is on the Research Team?

Amit X Garg, MD PhD FRCPC FACP

Principal Investigator

London Health Sciences Centre Research Institute

Pavel S Roshanov, MD MSc FRCPC

Principal Investigator

London Health Sciences Centre Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

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+

Published Research Related to This Trial

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]

Citations

1. nipro-group.com nipro-group.com/sites/default/files/2022-05/ELISIO%20HX%20-%20MM-2213%20-%20EN%20%20-%2018Mar2022%20-%20Approved_Original_3029%20%281%29.pdf

ELISIO™ HX Blood flow rate: 300 mL/min ; Dialysate flow rate: 500 mL/min; Treatment time: 240 min; N=6. Blood was collected pre- and post-dialysis to measure the reduction ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06660277

NCT06660277 | DIALysis With EXpanded Solute Removal The goal of this clinical trial is to evaluate the health effects of expanded hemodialysis in patients receiving hemodialysis.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9909626/

Efficacy and Safety of the Medium Cut-Off Elisio HX Dialyzer Super high-flux hemodialysis provides comparable effectiveness with high-volume postdilution online hemodiafiltration in removing protein ...

4. ctv.veeva.com ctv.veeva.com/study/dialysis-with-expanded-solute-removal

DIALysis With EXpanded Solute Removal - ClinicalTrials.Veeva The goal of this clinical trial is to evaluate the health effects of expanded hemodialysis in patients receiving hemodialysis.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/1744-9987.13919

Clinical performance comparison of two medium cut‐off ... In a randomized, controlled trial in maintenance hemodialysis patients, the new Nipro ELISIO-17HX MCO dialyzer was compared to the Baxter Theranova 400 filter.

6. d-nb.info d-nb.info/1280499354/34

Efficacy and Safety of the Medium Cut-Off Elisio HX Dialyzer Super high-flux he- modialysis provides comparable effectiveness with high-volume postdilution online hemo- diafiltration in removing ...