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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of dialyzer, the Theranova Dialyzer, for individuals with kidney failure undergoing dialysis. The researchers aim to determine if this dialyzer reduces symptoms by removing more toxins from the blood compared to the standard dialyzer. They will monitor symptoms through a smartphone app where patients can report how they feel after treatments. Individuals who have been on dialysis three times a week for at least three months and do not have a current infection, vision problems, or certain other health issues might be suitable for this trial. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance dialysis treatment.

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 prior data suggests that the Theranova Dialyzer is safe for hemodialysis patients?

Research shows that the Theranova Dialyzer is safe for people with kidney failure. Studies have demonstrated its effectiveness in removing large toxins from the blood. One study found that it slows the decline of kidney function more effectively than some other dialyzers. The FDA has approved the Theranova Dialyzer for use in patients with chronic kidney failure. Overall, patients have tolerated it well, and studies have reported no major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Theranova Dialyzer is unique because it targets larger middle molecules that traditional hemodialysis treatments often miss. While standard hemodialysis primarily focuses on removing small toxins and excess water, the Theranova Dialyzer goes a step further by filtering out these larger molecules, potentially leading to improved patient outcomes. Researchers are excited because this could mean better long-term health and quality of life for patients with kidney failure.

What evidence suggests that the Theranova Dialyzer is effective for reducing symptom burden in kidney failure?

Research has shown that the Theranova dialyzer can help treat kidney failure. In this trial, patients receiving hemodialysis will use the Theranova dialyzer during their regular sessions. Studies have found that it slows the progression of kidney function decline compared to other dialyzers. When used in expanded hemodialysis, the Theranova dialyzer is associated with a 25% lower risk of death from any cause. It also results in a 45% lower rate of hospital stays for patients on regular hemodialysis. Additionally, it more effectively removes larger waste molecules from the blood, which may help reduce symptoms caused by toxin buildup. ^{1 2 5 6 7}

Who Is on the Research Team?

Christopher McIntyre, MBBS DM

Principal Investigator

London Heath Sciences Centre

Are You a Good Fit for This Trial?

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

You are able and prepared to provide informed consent.

I am on a standard three times a week hemodialysis schedule.

I have been on hemodialysis for at least 3 months.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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 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 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 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]

Citations

1.

journals.lww.com

journals.lww.com/jasn/fulltext/2025/08000/expanded_hemodialysis_with_theranova_dialyzer_and.18.aspx

Expanded Hemodialysis with Theranova Dialyzer and ...

This trial suggests that expanded hemodialysis using the Theranova dialyzer slowed decline in residual kidney function compared with a high-flux dialyzer in ...

2.

baxter.com

baxter.com/baxter-newsroom/new-cohort-study-data-shows-baxters-expanded-hemodialysis-known-hdx-therapy

Known as HDx Therapy – is Associated with Approximately ...

New data showing expanded hemodialysis, known as HDx therapy, enabled by Theranova dialyzer, was associated with an approximately 25% lower all-cause mortality ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03257410

Theranova 400 Dialyzer In End Stage Renal Disease ...

The study evaluates the efficacy and safety of the Theranova 400 dialyzer compared with Elisio-17 H dialyzer in end stage renal disease patients receiving ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7480550/

Efficacy and Safety of Expanded Hemodialysis with the ...

Efficacy Outcomes​​ The Theranova 400 showed significantly larger removal of free λ light chains at 24 weeks of treatment than the Elisio-17H ...

5.

withpower.com

withpower.com/trial/phase-kidney-failure-chronic-10-2023-32a6f

Theranova Dialyzer for Kidney Failure

In a 24-week clinical trial involving 171 maintenance hemodialysis patients, the Theranova 400 dialyzer was associated with a 45% lower hospitalization rate ...

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/reviews/DEN190042.pdf

Hemodialyzer with expanded solute removal profile. A ...

Theranova Dialyzers are intended to treat chronic renal failure by removal of solutes and plasma water from the blood when used with a hemodialysis monitor ...

7.

investor.baxter.com

investor.baxter.com/investors/events-and-news/news/press-release-details/2020/Baxter-Announces-U.S.-FDA-De-Novo-Authorization-for-Theranova-Dialyzers-Enabling-HDx-Therapy/default.aspx

Baxter Announces U.S. FDA De Novo Authorization for ...

The Theranova Dialyzer is indicated for patients with chronic kidney failure who are prescribed intermittent hemodialysis. It provides an ...