Baxter International Inc. (NYSE:BAX), a global innovator in renal care, today announced new data showing use of Baxter’s Sharesource remote patient management (telehealth) platform for automated peritoneal dialysis (APD) therapy performed in Colombia was associated with a 56% reduction in technique failure. In a separate study conducted in Canada, data show 74% of patients, who received expanded hemodialysis (HDx) therapy enabled by Theranova, self-reported an improved quality of life through better energy, sleep, appetite and/or reduced pain. These studies were among the many presented in support of scientific exchange during the 57th ERA-EDTA Virtual Congress, June 6-9.
“Given the COVID-19 pandemic, there has never been a more important time for patients to perform dialysis in the safety of their own homes, or to receive therapy they report is improving their quality of life,” said Laura Angelini, general manager, Baxter’s Renal Care business. “While medical conferences have transitioned to virtual formats this year, we stand together with healthcare professionals on the importance of continuing to share data that contribute to our response of the unique needs patients have during the pandemic.”
Patients using Baxter’s APD systems with the Sharesource remote patient management platform can be closely monitored by their healthcare professionals without leaving their homes. Sharesource allows healthcare professionals to securely view their patients’ recently completed home dialysis-related treatment data that is automatically collected after each APD session. Healthcare professionals can then act on this information by remotely adjusting their patients’ home device settings without requiring them to make additional trips to the clinic.
Technique failure is a major barrier to increasing the use of APD. The abstract, “Clinical Outcomes in Remote Patient Monitoring Program in Automated Peritoneal Dialysis: A Colombian Experience,” [Abstract #P1151] shows promise in improving access to home therapy due to a reported 56% reduction in APD technique failure associated with those using Sharesource. The retrospective, multicenter study of 558 patients took place in Colombia from 2016-2018. Approximately 25% of the patients studied used Sharesource; the remainder used an APD system without remote patient management technology. There was not a significant difference in reported peritonitis rates across the patients in the study.
The study “Expanded Dialysis (HDx) – Is there an impact on patient reported symptoms,” [Abstract #P1062] highlighted data on patients’ self-reported improvements in quality-of-life metrics on HDx therapy enabled by Theranova. The 12-week study monitored 23 patients’ symptom characteristics throughout the study, two to three times weekly. Laboratory biomarkers, including beta-2 microglobulin and free-light chains, were also collected at baseline and after 12 weeks of HDx therapy. The authors stratified the patient population based on their baseline symptoms on conventional hemodialysis (using a high-flux membrane) and assessed patients’ experience of symptoms over time on HDx. Although more work is required to further stratify symptoms in relation to demographic/biochemical finding and clinical outcomes, 74% of the patients involved in the study reported improvement on at least one quality of life metric.
Theranova was designed to filter a wider range of molecules from the blood than conventional hemodialysis filters, targeting the removal of large middle molecules (25 kDa to < 60 kDa) that may be associated with inflammation and cardiovascular health for end-stage renal disease (ESRD) patients1,2,3. Its innovative MEDIUM CUT-OFF (MCO) membrane expands the range of solute removed during regular dialysis, while retaining essential proteins at a limited level. This unique cut-off and retention onset profile allows for filtration closer to that of the natural kidney4,5.
Theranova is an investigational device in the United States and is not approved or cleared in the U.S. HDx enabled by Theranova is available in Canada and select European, Latin American and Asian markets.
In response to the profound impact COVID-19 is having on how the medical community provides care during this time, Baxter also provided an unrestricted educational grant for two special sessions during ERA-EDTA that addressed, “Present situation on COVID-19 in Europe, globally and in Nephrology” and “Acute kidney injury, dialysis and transplantation in patients tested COVID-19 positive,” that were held during this year’s congress.
Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
This release includes forward-looking statements concerning Sharesource and Theranova, including availability and potential 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, Sharesource and Theranova are registered trademarks of Baxter International Inc.
1 Chmielewski et al. The Peptidic Middle Molecules: Is Molecular Weight Doing the Trick? Sem Nephrol 2014;34:118–34.
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 Boschetti-de-Fierro A, et al. MCO membranes: Enhanced Selectivity in High-Flux Class. Scientific Reports 2015; 5:18448
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