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

NCT06032208 | Recruiting

• 1 other identifier: 123850
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

End Stage Renal Disease

Keywords

Hemodialysis; Large middle molecules; Theranova

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (3)

• Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects cognition.

  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

  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.

  Between weeks 1 & 4 and repeated during week 28

Study Arms (1)

Patients receiving Hemodialysis

EXPERIMENTAL

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

Interventions

Theranova Dialyzer DEVICE

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.

Patients receiving Hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baxter Healthcare Corporation: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (4)

Seven Oaks Hospital Chronic Disease Innovation Centre Inc. (CDIC)

Winnipeg, Manitoba, R2V 3M3, Canada

RECRUITING

QEII Health Sciences Centre, Nova Scotia Health

Halifax, Nova Scotia, B3H 1V7, Canada

RECRUITING

Victoria Hospital, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Westmount Kidney Care Centre

London, Ontario, N6K 1M6, Canada

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher McIntyre, MBBS DM

  London Heath Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher McIntyre, MBBS DM

CONTACT

5196858500; Christopher.McIntyre@lhsc.on.ca

Jarrin Penny, PHD RN CNeph

CONTACT

519-685-8500; jarrin.penny@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Medical Biophysics and Paediatrics, Robert Lindsay Chair of Dialysis Research and Innovation

Model Details: Study visits take place within the patients usual hemodialysis unit consistent with their routinely scheduled dialysis sessions. Beginning week 5 participants will use the Theranova dialyzer until the end of dialysis week 28. Participants will answer 9 questions at least (1-3 times weekly) - weeks 1 through 28 (entire length of study) using the LEVIL application. Furthermore, participants answer a single Time-to-Recovery question between weeks 1-4 and repeated at week 28 to get more information on recovery time after dialysis in addition to completing Creyos (cognitive testing formally Cambridge Brain Sciences), as well as Sexual Desire Inventory-2 testing.

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 11, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CA (4)