End Stage Renal DiseaseNCT06032208
An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL
A study testing Theranova Dialyzer in people with End Stage Renal Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Theranova Dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesCanada
- Study dates
- 1 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
QEII Health Sciences Centre, Nova Scotia Health
Halifax, Nova Scotia, B3H 1V7
Laura Sills, RN, BSN, (902) 473-7625, laura.sills@nshealth.ca
David Clark, MD, MSc, FRCPC
- Recruiting
Victoria Hospital, London Health Sciences Centre
London, Ontario, N6A 5W9
Jarrin D Penny, RN, 519-685-8500 ext. 58765, jarrin.penny@lhsc.on.ca
- Recruiting
Westmount Kidney Care Centre
London, Ontario, N6K 1M6
Jarrin D Penny, RN, 519-685-8500 ext. 58765, jarrin.penny@lhsc.on.ca
- Recruiting
Seven Oaks Hospital Chronic Disease Innovation Centre Inc. (CDIC)
Winnipeg, Manitoba, R2V 3M3
Jordan Bankowski, BSc, (204) 631-3834 ext. (204) 631-3834, jbankowski@sogh.mb.ca
Oksana Harasemiw Harasemiw, (204) 632-3541, oharasemiw@sogh.mb.ca
About this study
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)
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.
Read the 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.
- Conditions
- End Stage Renal Disease
- Being tested
- Theranova Dialyzer
- Keywords
- Hemodialysis, Large middle molecules, Theranova
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theranova DialyzerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Theranova Dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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:
- Odd one Out (patterns), 2. Digit Span (number sequence), 3. Paired Association Task, 5. Rotations Task, 6. Monkey Ladder Task
Measured: 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
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.
Measured: 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.
Parameters will be measured using Time-to-Recovery question at baseline (between weeks 1 \& 4) and repeated at week 28.
Measured: Between weeks 1 & 4 and repeated during week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Christopher McIntyre, MBBS DM, Principal investigator, London Heath Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032208
- Sponsor's protocol ID
- 123850
- Status last verified
- Apr 2026
- First submitted
- 31 Aug 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06032208
- Acronym / sponsor ID
- 123850
- Conditions
- End Stage Renal Disease
- Keywords
- Hemodialysis, Large middle molecules, Theranova
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients receiving Hemodialysis | Experimental | Device: Theranova DialyzerA group of hemodialysis patients will be receiving the Theranova dialyzer during their regular scheduled dialysis sessions to remove larger middle molecules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theranova DialyzerThe 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. | Device | Patients receiving Hemodialysis |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher McIntyre, MBBS DM principal investigator
London Heath Sciences Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theranova Dialyzer in people with End Stage Renal Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher McIntyre, MBBS DM (5196858500 ext. 58502, Christopher.McIntyre@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Beginning week 1 and ending at the end of dialysis on week 28.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.