An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL

April 28, 2026 updated by: Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

An Extension of an Interventional Study to Assess the Effect of Expanded Dialysis (HDx-Theranova) on Patient Reported Symptoms Using London Evaluation of Illness (LEVIL)

Investigators know that many patients who are on dialysis suffer from burden of unwanted symptoms, which can affect quality of life. The understanding and treatment of symptom burden by healthcare providers is limited and should be recognized as a high priority in the care of the dialysis population. In this study, the investigators will be assessing symptom burden using the London Evaluation of Illness "LEVIL," an application based platform where patients self-report their symptoms with one to three hemodialysis treatments per week for 28 weeks. The investigators would like to compare the currently available dialyzer with a new dialyzer that is capable of removing solutes of higher molecular weight that may or may not cause patients to experience symptoms related to increased amounts of toxins in their blood.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Baxter Canada has an expanded hemodialysis (HDx) membrane called the "Theranova", which is capable of removing solutes of higher molecular weight. Although this clearly has biochemical advantages it is not known at this time if the removal of larger middle molecules can have a direct and immediate effect on patients reported symptoms and quality of life. In short, do people actually feel better?

Given the way many quality of life measurements fluctuate around the dialysis week, the investigators propose to utilize a dynamic tool. The investigators will be assessing symptom burden using the London Evaluation of Illness "LEVIL" an application based platform where patients self-report their symptoms with at least one hemodialysis treatment. Reports are generated immediately and in real-time, which cannot be accomplished with other symptom management tools. This allows the investigators to track study changes and benchmark observations to previously established baseline values. The investigators are excited to see if there is an imminent effect on how patients feel using the Theranova dialyzer.

The study is investigator initiated and the principal investigator has secured modest funding from Baxter to allow support for the core study team and the introduction and maintenance of the LEVIL evaluation platform at other centers. Baxter have also provided some dialyzer support and will work with individual centers to ensure that there is no consumable increment of cost associated with participation.

The study is 28 weeks in length:

  • LEVIL entries with at least 1 to 3 hemodialysis treatments each week for 28 weeks.
  • Implementation of Theranova dialyzer from week 5 until the end of week 28.
  • Creyos (cognitive testing) one time at baseline (between weeks 1 to 4) and again during week 28.
  • Sexual Desire questionnaire one time at baseline (between weeks 1 to 4) and again during week 28.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2V 3M3
        • Recruiting
        • Seven Oaks Hospital Chronic Disease Innovation Centre Inc. (CDIC)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Clara Bohm, MD, MPH, FRCPC
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Recruiting
        • QEII Health Sciences Centre, Nova Scotia Health
        • Contact:
        • Principal Investigator:
          • David Clark, MD, MSc, FRCPC
    • Ontario
      • London, Ontario, Canada, N6K 1M6
        • Recruiting
        • Westmount Kidney Care Centre
        • Contact:
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Victoria Hospital, London Health Sciences Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Conventional thrice weekly HD schedule
  • Must be on chronic hemodialysis for at least 3 months
  • Age ≥18 years
  • Willing and able to give informed consent

Exclusion Criteria:

  • Active infection (may enroll once infection is cleared)
  • Patients receiving daily hemodialysis treatment
  • Patients currently receiving Hemodiafiltration (HDF), Hemofiltration (HF) or Isolated ultrafiltration (ISO UF) more than once in three months
  • Visual impairment
  • History of neurocognitive impairment
  • History of stroke (CVA)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients receiving Hemodialysis
A group of hemodialysis patients will be receiving the Theranova dialyzer during their regular scheduled dialysis sessions to remove larger middle molecules.
Device: Theranova Dialyzer
The Theranova dialyzer will be used for each of the hemodialysis treatments beginning week 5 and ending at the end of dialysis week 28. This will allow us to compare patient reported symptoms in weeks 1-4 on their usual dialyzer with with their symptoms on the Theranova dialyzer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx -Theranova) effects patient reported symptoms as determined by LEVIL.
Time Frame: Beginning week 1 and ending at the end of dialysis on week 28.

The primary outcome will be a change (from patient's own baseline) in general well-being, pain, sleep. breathing, energy, appetite, itch, restless legs, and recovery from hemodialysis when using the Theranova dialyzer. These parameters will be measured using the LEVIL, an electronic application based visual analog scale.

The scale indicates Very Poor on the left and Excellent to the right or Extreme on the left to No Problem on the right. Participants will use their finger and slide the scale to indicate which best describes how they feel.
Beginning week 1 and ending at the end of dialysis on week 28.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects cognition.
Time Frame: Between weeks 1 & 4 and repeated during week 28

Cognitive Testing measured using Creyos (formally Cambridge Brain Sciences) web-based application at baseline (between weeks 1 & 4) and repeated at week 28.

Creyos consists of tasks that are separated into domains of reasoning, short term memory, and verbal abilities:

1. Odd one Out (patterns), 2. Digit Span (number sequence), 3. Paired Association Task, 5. Rotations Task, 6. Monkey Ladder Task
Between weeks 1 & 4 and repeated during week 28
Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects sexual desire
Time Frame: Between weeks 1 & 4 and repeated during week 28

Parameters will be measured using Sexual Desires Inventory-2 (SDI-2) an anonymous web-based platform at baseline (between weeks 1 & 4) and repeated at week 28.

SDI-2 is a multiple choice platform where participants will privately answer questions that best describes how they feel. (eg. not at all, once a month, once every two months, once a week, twice a week, 3 to 4 times a week, once a day, more then once a day) A score will be populated within the app and the score will be recorded only.
Between weeks 1 & 4 and repeated during week 28
Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects dialysis recovery time compared to high-flux dialysis membrane.
Time Frame: Between weeks 1 & 4 and repeated during week 28
Parameters will be measured using Time-to-Recovery question at baseline (between weeks 1 & 4) and repeated at week 28.
Between weeks 1 & 4 and repeated during week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Baxter Healthcare Corporation

Investigators

  • Principal Investigator: Christopher McIntyre, MBBS DM, London Heath Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

September 8, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123850

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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