Theranova Dialyzer for Kidney Failure
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byChristopher McIntyre, MBBS DM
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Lawson Health Research Institute
Disqualifiers: Active infection, Visual impairment, Neurocognitive impairment, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the Theranova Dialyzer treatment for kidney failure?
How is the Theranova Dialyzer treatment different from other treatments for kidney failure?
Eligibility Criteria
This trial is for adults over 18 who have been on hemodialysis for at least three months due to chronic kidney failure. They must be following a conventional dialysis schedule of three times per week and be willing to report their symptoms using the LEVIL app.Inclusion Criteria
I am on a standard three times a week hemodialysis schedule.
I have been on hemodialysis for at least 3 months.
I am 18 years old or older.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-4 weeks
1 visit (in-person)
Baseline Assessment
Baseline cognitive testing and sexual desire questionnaire conducted
1-4 weeks
1 visit (in-person)
Treatment
Participants receive hemodialysis with the Theranova dialyzer and report symptoms using LEVIL
28 weeks
1-3 visits per week (in-person)
Follow-up
Participants are monitored for changes in cognition and sexual desire
1 week
1 visit (in-person)
Treatment Details
Interventions
- Theranova Dialyzer (Other)
Trial OverviewThe study is testing a new Theranova Dialyzer against the current standard one. It aims to see if the new dialyzer, which removes larger toxins from blood, can reduce symptom burden in patients undergoing up to three hemodialysis treatments weekly for 28 weeks.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Patients receiving HemodialysisExperimental Treatment1 Intervention
A group of hemodialysis patients will be receiving the Theranova dialyzer during their regular scheduled dialysis sessions to remove larger middle molecules.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Westmount Kidney Care CentreLondon, Canada
Victoria Hospital, London Health Sciences CentreLondon, Canada
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Who Is Running the Clinical Trial?
Lawson Health Research InstituteLead Sponsor
London Health Sciences Centre OR Lawson Research Institute of St. Joseph'sLead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sLead Sponsor
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph'sLead Sponsor
Baxter Healthcare CorporationIndustry Sponsor
References
The NxStage System One. [2004]Given the results of recent randomized controlled trials as well as staffing and budget challenges that today face many institutions across North America, a novel therapeutic approach is likely necessary to enable improvements in clinical outcomes for renal failure patients. The NxStage System One was developed to address these challenges. The system is an innovative, flexible device that delivers hemodialysis, hemofiltration, and/or ultrafiltration therapies to patients with renal failure or fluid overload. The unique characteristics of this system include a highly automated system design with a drop-in cartridge to facilitate training and simple operation; portable size and independence from dedicated infrastructure to minimize practical barriers to where therapy may be administered; use of high-quality premixed treatment fluids to enable capture of the potential clinical benefits of fluid purity without the hassles of local water treatment; and wide operating ranges to allow clinician flexibility in patient therapy prescriptions. In both the chronic and acute care environments, the System One presents clinicians with a new platform for delivering patient therapy improvements within real-world constraints.
Low-flux versus high-flux synthetic dialysis membrane in acute renal failure: prospective randomized study. [2019]The influence of dialyzer membrane on the morbidity and mortality of patients with acute renal failure remains a matter of debate. The aim of the prospective randomized clinical study was to assess the influence of the flux of a synthetic dialyzer membrane on patients' survival rate, restitution of renal function, and duration of hemodialysis treatment of patients with acute renal failure as a part of multiorgan failure. Seventy-two patients treated in intensive care units of the University Medical Center Ljubljana were randomized according to the dialyzer used throughout the duration of hemodialysis treatment. There were 38 patients in the low-flux group (dialyzer F6, low-flux polysuphone, Fresenius, Bad Homburg, Germany) and 34 patients in the high-flux group (dialyzer Filtral 12, sulphonated high-flux polyacrylonitrile, Hospal, Industrie Meyzieu, France). Both groups were balanced in terms of sex, age, APACHE II score, oliguria before dialysis, cause of acute renal failure, inotropic support, mechanical ventilation, and the number of failing organs. The patients' survival rate was 18.7% in the low-flux group and 20.6% in the high-flux group. Ten patients (26.3%) recovered their renal function in the low-flux group and 8 (23.5%) in the high-flux group. Hemodialysis treatment lasted 11.2 days in the low-flux and 10.7 days in the high-flux group. An analysis of subgroups with a lower mortality rate (subgroup of patients without oliguria and subgroup of patients with less than 4 failed organ systems) did not show significant differences between the low-flux and high-flux groups in terms of survival rate, recovery of renal function, and duration of hemodialysis treatment. In conclusion, no significant differences were found in the results of low-flux versus high-flux synthetic membrane dialyzer treatment in patients with acute renal failure as a part of multiorgan failure in terms of survival rate, recovery of renal function, incidence of oliguria during hemodialysis, and duration of hemodialysis treatment. The number of failing organs seems to be the most important single factor determining the survival of patients with acute renal failure as a part of multiorgan failure.
Economic evaluation of expanded hemodialysis with the Theranova 400 dialyzer: A post hoc evaluation of a randomized clinical trial in the United States. [2022]The Theranova 400 is a medium cut-off dialyzer that allows for superior clearance of larger middle molecules than traditional high-flux dialyzers. This study evaluates the association of expanded hemodialysis (HDx) using the Theranova dialyzer versus conventional hemodialysis (HD) with a high-flux dialyzer on hospitalization rates and healthcare costs as compared to conventional HD in a post hoc analysis of a randomized controlled trial.
Clinical Outcomes With Medium Cut-Off Versus High-Flux Hemodialysis Membranes: A Systematic Review and Meta-Analysis. [2022]A novel medium cut-off (MCO) dialyzer (Theranova, Baxter Healthcare, Deerfield, IL, USA) enhances large middle molecule clearance while retaining selectivity for molecules >45 000 Da.
Do clinical outcomes in chronic hemodialysis depend on the choice of a dialyzer? [2011]Nephrologists are presented with a range of choices when selecting a dialyzer for chronic hemodialysis. Dialyzers differ in the material, structure, permeability and surface area of their membrane, and how the dialyzer is sterilized. Opinions vary regarding the impact of dialyzer characteristics on patient outcomes and which, if any, of these properties to take into account when choosing a dialyzer can be confusing. In the general dialysis population, there is no compelling evidence that the choice of a membrane material from among those materials currently in clinical use has a significant impact on morbidity or mortality (although there are rare patients who will react adversely to a given dialysis membrane). Similarly, most dialyzers are capable of adequately removing small solutes, such as urea, provided they are used with an appropriate blood flow rate and treatment time to ensure delivery of a single-pool Kt/V(urea) of at least 1.25 for men and 1.65 for women. However, in some dialysis patient subpopulations, the results of randomized clinical trials suggest that use of dialyzer containing high-flux membranes confers an outcome advantage. The extent to which this advantage is realized might also depend on how the dialyzer is used, with application in convective therapies such as hemodiafiltration being superior to diffusive therapies such as hemodialysis. This possibility is currently the subject of several large clinical trials.
[Influence of various dialyzers on acid-base balance in hemodialysis]. [2006]Various dialyzers and acid-base balance in haemodialysis: 12 patients aged 32 to 52 years in periodic haemodialysis (4hx3) with residue diuresis absent, were examined during four trimestrial cycles with four different dialyzers (Nephross 16 F I60, Gambro Lundia Optima I3,5 micron, RP 5I0, Vita 2). The acid-base balance was examined 30 days after starting of each cycle. The results are reported and discussed.
Evaluation of the Gambro Lundia Major 1.36 m2 disposable parallel plate dialyzer. [2019]The Gambro Lundia Major 1.36 m2 dialyzer was assessed in vivo in ten hemodialysis patients. Urea and creatinine clearances (measured as whole blood values at 60 minutes with a blood flow rate of 200 ml/minute) were 166 +/- 8 m/minute (mean +/- standard error of the mean, n = 9) and 115 +/- 4 ml/minute (n = 11). The creatinine clearance is 15% lower than in vitro data. There was a marked decrease in urea and creatinine clearance with third use of the dialyzer. The ultrafiltration rate was 490 ml/hour/100 mmHg. The priming volume was 125 ml (at a transmembrane pressure of 100 mmHg) and residual blood volume in the dialyzer was 0.57 +/- 0.11 ml (n = 5). The handling, storage and ease of disposal of the dialyzer is better than previous models and its performance characteristics are clinically acceptable.