New cohort study data shows Baxter's expanded hemodialysis – known as HDx therapy – is associated with approximately 25% lower mortality rate for up to four years

Expanded Hemodialysis
  • Four-year study involved more than 1,000 dialysis patients from a large dialysis provider in Colombia

     

  • Study compared Baxter's HDx therapy enabled by Theranova dialyzer with high-flux hemodialysis

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Baxter International Inc. (NYSE:BAX), a global innovator in kidney care and vital organ support, today announced new data showing expanded hemodialysis, known as HDx therapy, enabled by Theranova dialyzer, was associated with an approximately 25% lower all-cause mortality risk for up to four years when compared to high-flux hemodialysis (HF HD). The study, “Survival of expanded hemodialysis and high-flux hemodialysis patients in Colombia: a cohort study,” was presented at the 61st Congress of the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress, May 23-26.

The new data is from a 48-month observational cohort study involving 1,092 dialysis patients at 11 Baxter Renal Care Services Centers in Colombia. In the study, 533 patients received high-flux hemodialysis and were compared to 559 patients who received HDx therapy. HDx therapy targets the efficient removal of large-middle molecules,1,2,3,4 allowing for filtration closer to that of the natural kidney.5,6 Many of these large-middle molecule uremic toxins have been linked to the development of inflammation, cardiovascular disease, and other comorbidities in dialysis patients.1,2,3,7HDx therapy uses Baxter's Theranova dialyzer equipped with the MCO membrane, which filters a wider range of middle molecule uremic toxins from the blood, specifically targeting the large-middle molecules not effectively removed by conventional hemodialysis therapies. 

It is very exciting to see the results of this four-year study, indicating approximately 25% lower mortality for chronic kidney patients with the use of Baxter's Theranova dialyzer. Dialysis treatments that more closely mimic the natural kidney have been associated with lower comorbidities, offering a protective effect for kidney patients.

Professor Peter Rutherford, MB BS, PhD

Vice president, Medical Affairs, Kidney Care, Baxter

In addition to its clearance profile, HDx therapy enabled by Theranova dialyzer is as simple to perform as conventional hemodialysis (HD) and was designed to work with all HD machines. This allows clinics to offer HDx therapy using existing resources and eliminates the need for special equipment and added clinic workflow, which is required for HDF. More than 14 million dialysis treatments have been performed worldwide using Theranova dialyzer in more than 850 clinics. More information on Baxter's HDx therapy can be found at the below link.

ERA-EDTA 2024 presentations

ERA-EDTA 2024 presentations can be viewed on the congress website. To access the specific abstract, click on the link below and refer to citation ID: gfae069.1521.


About THERANOVA Dialyzer

Theranova dialyzer is indicated for patients with chronic kidney failure who are prescribed intermittent hemodialysis. It provides an expanded solute removal profile with increased effective removal of various middle molecules (up to 45 kDa) that may play a pathologic role in the uremic clinical syndrome. Theranova dialyzer is not intended for hemofiltration or hemodiafiltration therapy. The total extracorporeal blood volume for Theranova dialyzer and the set should represent less than 10% of the patient's blood volume. 

For single use only. 


About Vantive

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. Today, patients across more than 100 countries around the world interact with Vantive’s people, solutions and services over 1 million times each day. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility, efficiency and therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. To learn more, visit www.vantive.com and follow us on LinkedInXFacebookInstagram, and YouTube.

Rx only. For the safe and proper use of this device, refer to the Instructions for Use.

 

This release includes forward-looking statements concerning HDx therapy and Baxter's Theranova dialyzer equipped with the MCO membrane, including their potential impact on patients and anticipated benefits associated with their use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.

 

Baxter, HDx, MCO and Theranova are trademarks of Baxter International Inc. or its subsidiaries.

Références
  1. Hutchison CA, et al. The Rationale for Expanded Hemodialysis Therapy (HDx). Contrib Nephrol. 2017; 191:142-52.

  2. Neirynck N, et al. An update on uremic toxins. Int Urol Nephrol. 2013; 45:139-50.

  3. Duranton F, et al. European Uremic Toxin Work Group. Normal and pathologic concentrations of uremic toxins. J Am Soc Nephrol. 2012 Jul; 23(7):1258-70.

  4. Rosner M, et al. Classification of Uremic Toxins and Their Role in Kidney Failure. Clin J Am Soc Nephrol. 2021;16(12):1918-1928.

  5. Zweigart C, et al. Medium cut-off membranes – closer to the natural kidney removal function. Int J Artif Organs. 2017; 40(7):328-334.

  6. Boschetti-de-Fierro A, et al. MCO membranes: Enhanced Selectivity in High-Flux Class. Scientific Reports 2015; 5:18448.

  7. Ronco C, et al. The rise of Expanded Hemodialysis. Blood Purif. 2017; 44:I–VIII.. Doi: 10.1159/000476012.