Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL

Interventional Study to Assess the Effect of Expanded Dialysis Using the Theranova Dialyzer on Patient Reported Symptoms Using the London Evaluation of Illness (LEVIL)

Investigators know that many patients who are on dialysis suffer from the burden of unwanted symptoms, which can affect quality of life. 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 at least one hemodialysis treatment. 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 these toxins in their blood.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Device: Theranova Dialyzer

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 be people actually feel better?

Given the way many QoL 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 60 weeks in length:

• LEVIL entries with at least one hemodialysis treatment each week for 60 weeks
• Blood sampling at 4 time points for all participants
• Implementation of Theranova dialyzer from weeks 5 through 16 and weeks 25 through 48
• Wash out period from weeks 17 through 24 and weeks 49 through 60
• Time to recovery question at the first treatment of weeks 1, 16, 24, and 48 for new participants
• 5-D Pruritus scale and Restless Legs Syndrome rating scale at the first treatment of weeks 1, 16, 24, and 48
• Echocardiogram prior to starting hemodialysis and at peak stress at baseline (within the first two weeks), with one treatment between weeks 12 to 16 which will occur mid-week, and with one treatment between weeks 44 to 48 which will occur mid-week (LHSC specific)
• CVInsight monitoring at baseline (within the first two weeks), with one treatment between weeks 2 to 16, 20 to 25, and with one treatment between weeks 44 to 48 (LHSC specific)
• Non-invasive assessment of cardiovascular risk using the AGE Reader within 1 hour of starting hemodialysis at baseline, with one treatment between weeks 12 to 16, 20 to 24, and with one treatment between weeks 44 to 48 which will occur mid-week (LHSC specific)
• Five Time Sit to Stand Test & 60-Second Chair Test at the second treatment of weeks 1, 16, 24, and 48

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6K 1M6
      • Kidney Care Centre
    • London, Ontario, Canada, N6A 5W9
      • Adam Linton Dialysis Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Chronic hemodialysis patient
• Must be on hemodialysis for at least 3 months
• Age ≥18 years
• Willing and able to give informed consent

Exclusion Criteria:

• Active infection
• Active cancer
• Life expectancy <1 year as estimated by care provider
• Hemodialysis patients currently receiving Hemodiafiltration (HDF), Hemofiltration (HF) or Isolated ultrafiltration (ISO UF)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

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 regularly scheduled sessions to remove larger middle molecules

Device: Theranova Dialyzer; The Theranova dialyzer will be used for each of the hemodialysis treatments beginning week 3 and ending at the end of the dialysis week on week 14 and again starting week 23 and ending at the end of the dialysis week on week 46 . This will allow us to compare patient reported symptoms in weeks 1 and 2 when patients are on their usual dialyzer with their symptoms using the Theranova dialyzer. This will also allow us to see if there is a carry-over effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A change in larger middle molecule induced symptoms as assessed by the LEVIL application	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.	Beginning week 1 and ending at the end of the dialysis week on week 46

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A change in larger middle molecule clearance using the Theranova dialyzer	The secondary outcome is a change in the clearance of large middle molecules which will be evaluated by measuring levels of beta-2 microglobulin, beta-12 binding globulin, free light chains (kappa, lambda), factor D, fibroblast growth factor 23, and interleukin 6.	First treatment of weeks 1, 14, and 46
Correlation between large middle molecules and patient symptoms	Another secondary outcome is the relationship between the clearance of large middle molecules and specific symptoms reported by the patients using the LEVIL application.	Beginning week 1 and ending at the end of the dialysis week on week 54
A change in symptoms with a change in dialyzer (usual to Theranova and vice versa)	Another secondary outcome is if the time point where symptoms change with a change in dialyzer	Beginning week 1 and ending at the end of the dialysis week on week 54
Effect on microcirculation and/or hemodialysis induced circulatory stress with the Theranova dialyzer	Another secondary outcome is the Theranova dialyzer effect on microcirculation and/or hemodialysis induced circulatory stress	Beginning week 3 and ending at the end of the dialysis week on week 14 and again week 23 and ending week 46

Collaborators and Investigators

• 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 Health Sciences Centre

Publications and helpful links

General Publications

• Penny JD, Jarosz P, Salerno FR, Lemoine S, McIntyre CW. Impact of Expanded Hemodialysis Using Medium Cut-off Dialyzer on Quality of Life: Application of Dynamic Patient-Reported Outcome Measurement Tool. Kidney Med. 2021 Jul 29;3(6):992-1002.e1. doi: 10.1016/j.xkme.2021.05.010. eCollection 2021 Nov-Dec.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hemodialysis; Larger middle molecules; Theranova
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 1589

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