Clinical trial NCT06032208: An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Hemodialysis
Large middle molecules
Theranova
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2023-09-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: Beginning week 1 and ending at the end of dialysis on week 28.
Secondary outcomes:
measure: Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects cognition.
timeFrame: Between weeks 1 & 4 and repeated during week 28
measure: Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects sexual desire
timeFrame: Between weeks 1 & 4 and repeated during week 28
measure: 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.
timeFrame: Between weeks 1 & 4 and repeated during week 28
Other outcomes:
Locations:
city: London
country: Canada
facility: Victoria Hospital, London Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: Westmount Kidney Care Centre
state: Ontario
Study officials:
affiliation: London Heath Sciences Centre
name: Christopher McIntyre, MBBS DM
role: PRINCIPAL_INVESTIGATOR
References: