An interventional study of Theranova Dialyzer in End Stage Renal Disease, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-24.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment
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.
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:
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 261 are open to participants now.
This study's enrollment of 82 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: Beginning week 1 and ending at the end of the dialysis week on week 46
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.
Time frame: 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.
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)
Another secondary outcome is if the time point where symptoms change with a change in dialyzer
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
Another secondary outcome is the Theranova dialyzer effect on microcirculation and/or hemodialysis induced circulatory stress
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
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's