End Stage Renal DiseaseNCT03640858
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 2 sites in Canada.
Trial summary
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… 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
- 82 participants
- Where
- 2 sitesCanada
- Study dates
- 8 May 2019to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Chronic hemodialysis patient
- Must be on hemodialysis for at least 3 months
- Age ≥18 years
- Willing and able to give informed consent
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Adam Linton Dialysis Unit
London, Ontario, N6A 5W9
Kidney Care Centre
London, Ontario, N6K 1M6
About this study
Official title: 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.
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 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
- Conditions
- End Stage Renal Disease
- Being tested
- Theranova Dialyzer
- Keywords
- Hemodialysis, Larger 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving hemodialysis | Experimental | A group of hemodialysis patients will be receiving the Theranova dialyzer during their regularly scheduled 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.
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.
Measured: Beginning week 1 and ending at the end of the dialysis week on week 46
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Beginning week 3 and ending at the end of the dialysis week on week 14 and again week 23 and ending week 46
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start8 May 2019
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 and 25 participants use the Theranova dialyzer until the end of the dialysis week on week 16 and 48. Participants answer 9 questions at least at one session regarding symptoms experienced since their last session using the LEVIL application. Furthermore, participants answer a single time to recovery question at the first treatment of weeks 1, 16, 24, and 48 to get more detailed information on recovery time after dialysis in addition to completing the 5-D Pruritus and the Restless Legs Syndrome scales. Bloodwork is drawn at 4 intervals throughout the study for laboratory evaluation. Participants have an echo at baseline and between weeks 12 to 16, 20-24 and 44-48 while on the Theranova dialyzer. In addition to this, participants will have non-invasive monitoring of circulatory stress using the CVInsight contact device.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
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
- Investigators
- Christopher McIntyre, MBBS DM, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640858
- Sponsor's protocol ID
- 1589
- Status last verified
- Mar 2024
- First submitted
- 14 Aug 2018
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34939008
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study to Assess the Effect of Expanded Dialysis Using the Theranova Dialyzer on Patient Reported Symptoms Using the London Evaluation of Illness (LEVIL)
- ClinicalTrials.gov ID
- NCT03640858
- Acronym / sponsor ID
- 1589
- Conditions
- End Stage Renal Disease
- Keywords
- Hemodialysis, Larger middle molecules, Theranova
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- 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
- 8 May 2019 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 21 Aug 2018 (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 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.
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 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 and 25 participants use the Theranova dialyzer until the end of the dialysis week on week 16 and 48. Participants answer 9 questions at least at one session regarding symptoms experienced since their last session using the LEVIL application. Furthermore, participants answer a single time to recovery question at the first treatment of weeks 1, 16, 24, and 48 to get more detailed information on recovery time after dialysis in addition to completing the 5-D Pruritus and the Restless Legs Syndrome scales. Bloodwork is drawn at 4 intervals throughout the study for laboratory evaluation. Participants have an echo at baseline and between weeks 12 to 16, 20-24 and 44-48 while on the Theranova dialyzer. In addition to this, participants will have non-invasive monitoring of circulatory stress using the CVInsight contact device.
| Arm | Type | Receives |
|---|---|---|
| Patients receiving hemodialysis | Experimental | Device: Theranova DialyzerA group of hemodialysis patients will be receiving the Theranova dialyzer during their regularly scheduled 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)
- Chronic hemodialysis patient
- Must be on hemodialysis for at least 3 months
- Age ≥18 years
- Willing and able to give informed consent
Key exclusion criteria (4 listed)
- 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)
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 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. | Device | Patients receiving hemodialysis |
Primary outcome
A change in larger middle molecule induced symptoms as assessed by the LEVIL application
Time frame: Beginning week 1 and ending at the end of the dialysis week on week 46
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.
4 secondary outcomes
A change in larger middle molecule clearance using the Theranova dialyzer
Time frame: First treatment of weeks 1, 14, and 46
Correlation between large middle molecules and patient symptoms
Time frame: 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)
Time frame: 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
Time frame: Beginning week 3 and ending at the end of the dialysis week on week 14 and again week 23 and ending week 46
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Derived from this study: PubMed 34939008Penny 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.
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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. This study is not recruiting at the moment.
Christopher McIntyre, MBBS DM principal investigator
London Health Sciences Centre
2 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 2 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 4 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: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change in larger middle molecule induced symptoms as assessed by the LEVIL application (time frame: Beginning week 1 and ending at the end of the dialysis week on week 46). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640858, which also lists 1 linked publication.
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 24 Dec 2024.