Theranova Dialyzer for Kidney Failure

Recruiting at 1 trial location

Overseen By Jarrin Penny, PHD RN CNeph

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Disqualifiers: Active infection, Visual impairment, Neurocognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 28 weeks

100 Participants Needed

Trial Summary

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?

The Theranova Dialyzer is shown to clear larger middle molecules more effectively than traditional high-flux dialyzers, which may help reduce hospitalization rates and healthcare costs for patients undergoing hemodialysis. ^{1 2 3 4 5}

How is the Theranova Dialyzer treatment different from other treatments for kidney failure?

The Theranova Dialyzer is unique because it uses a medium cut-off membrane that allows for better removal of larger waste molecules from the blood compared to traditional high-flux dialyzers, potentially reducing hospitalization rates and healthcare costs. ^{2 3 4 6 7}

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.

Research Team

Christopher McIntyre, MBBS DM

Principal Investigator

London Heath Sciences Centre

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.

You are able and prepared to provide informed consent.

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

Trial Overview The 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

Group I: Patients receiving Hemodialysis Experimental Treatment 1 Intervention

A group of hemodialysis patients will be receiving the Theranova dialyzer during their regular scheduled dialysis sessions to remove larger middle molecules.

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

Baxter Healthcare Corporation

Industry Sponsor

Trials

328

Recruited

203,000+

Dr. Heather Knight

Baxter Healthcare Corporation

Chief Medical Officer

MD

Brent Shafer

Baxter Healthcare Corporation

Chief Executive Officer

Bachelor's degree in Business Administration

Findings from Research

The NxStage System One is an innovative hemodialysis device designed to improve clinical outcomes for renal failure patients, addressing challenges like staffing and budget constraints in healthcare settings.

Its features, such as portability, automated operation, and use of high-quality treatment fluids, allow for flexible and efficient therapy delivery in both chronic and acute care environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The NxStage System One. Clark, WR., Turk, JE.[2004]

In a study of 72 patients with acute renal failure, there were no significant differences in survival rates, recovery of renal function, or duration of hemodialysis treatment between those using low-flux and high-flux dialyzer membranes.

The most critical factor affecting patient survival was the number of failing organs, rather than the type of dialyzer membrane used during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-flux versus high-flux synthetic dialysis membrane in acute renal failure: prospective randomized study. Ponikvar, JB., Rus, RR., Kenda, RB., et al.[2019]

In a 24-week clinical trial involving 171 maintenance hemodialysis patients, the Theranova 400 dialyzer was associated with a 45% lower hospitalization rate compared to traditional high-flux dialyzers, indicating improved patient outcomes.

The use of the Theranova dialyzer resulted in an estimated annual cost savings of $6098 per patient due to reduced hospitalizations, highlighting its potential for lowering healthcare costs in hemodialysis treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic evaluation of expanded hemodialysis with the Theranova 400 dialyzer: A post hoc evaluation of a randomized clinical trial in the United States. Blackowicz, MJ., Falzon, L., Beck, W., et al.[2022]

The novel medium cut-off (MCO) dialyzer significantly improves quality of life and reduces symptoms like pruritus and recovery time in patients undergoing hemodialysis, based on a systematic review of 22 studies involving 1811 patients.

While the MCO dialyzer shows benefits in quality of life and reduces hospitalization and infection rates, it does not appear to affect all-cause mortality or serious adverse events, indicating it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes With Medium Cut-Off Versus High-Flux Hemodialysis Membranes: A Systematic Review and Meta-Analysis. Kandi, M., Brignardello-Petersen, R., Couban, R., et al.[2022]

In general, the choice of dialyzer membrane material does not significantly affect morbidity or mortality in the dialysis population, although some patients may have adverse reactions to specific membranes.

High-flux dialyzers may offer better outcomes for certain patient subpopulations, especially when used in convective therapies like hemodiafiltration, which is currently being investigated in large clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do clinical outcomes in chronic hemodialysis depend on the choice of a dialyzer? Ward, RA.[2011]

In a study involving 12 patients undergoing periodic hemodialysis, the acid-base balance was assessed after using four different types of dialyzers over four cycles, indicating the importance of dialyzer selection in managing acid-base levels.

The examination of acid-base balance 30 days after starting each cycle suggests that different dialyzers may have varying impacts on patients' biochemical stability during hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Influence of various dialyzers on acid-base balance in hemodialysis]. Bellinghieri, G., Savica, V., Mallamace, A., et al.[2006]

The Gambro Lundia Major 1.36 m2 dialyzer demonstrated clinically acceptable performance in hemodialysis, with urea and creatinine clearances of 166 ml/min and 115 ml/min, respectively, in a study involving ten patients.

However, the creatinine clearance was 15% lower than expected based on in vitro data, and there was a significant decrease in clearance observed after the third use of the dialyzer, indicating potential limitations in its longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Gambro Lundia Major 1.36 m2 disposable parallel plate dialyzer. Dziukas, LJ., Douglas, SM., Carter, PM., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

The NxStage System One. [2004]

2. United States pubmed.ncbi.nlm.nih.gov

Low-flux versus high-flux synthetic dialysis membrane in acute renal failure: prospective randomized study. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

Economic evaluation of expanded hemodialysis with the Theranova 400 dialyzer: A post hoc evaluation of a randomized clinical trial in the United States. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Clinical Outcomes With Medium Cut-Off Versus High-Flux Hemodialysis Membranes: A Systematic Review and Meta-Analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Do clinical outcomes in chronic hemodialysis depend on the choice of a dialyzer? [2011]

6. Italy pubmed.ncbi.nlm.nih.gov

[Influence of various dialyzers on acid-base balance in hemodialysis]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Gambro Lundia Major 1.36 m2 disposable parallel plate dialyzer. [2019]