DIALysis With EXpanded Solute Removal

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).

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

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.

Sponsors & Collaborators

• Schulich School of Medicine and Dentistry

  collaborator UNKNOWN

• ICES

  collaborator INDUSTRY

• Nipro Canada Corporation

  collaborator UNKNOWN

• London Health Sciences Centre

  collaborator OTHER

• Statistics Canada

  collaborator UNKNOWN

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

  lead OTHER

Principal Investigators

• Pavel S Roshanov, MD MSc FRCPC · London Health Sciences Centre Research Institute

• Amit X Garg, MD PhD FRCPC FACP · London Health Sciences Centre Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-12

Primary Completion

2030-08-31

Completion

2030-08-31

Countries

• Canada

Study Locations