Baxter Highlights Clinical Data at ASN: Kidney Week Showing How New Technologies Are Advancing Dialysis Care across Modalities

• Thirteen studies presented on HDx therapy enabled by Theranova adding to significantly growing global clinical evidence
• Two telehealth studies highlighted reduced hospitalizations and cost efficiencies for home PD patients using the Sharesource remote patient management platform

SAN DIEGO – October 29, 2018 –(BUSINESS WIRE)–Baxter International Inc. (NYSE:BAX), a global innovator in renal care, highlighted findings from HDx (expanded hemodialysis) and peritoneal dialysis (PD) studies presented at the American Society of Nephrology (ASN): Kidney Week, Oct. 23-28, showing how novel renal care technologies are positively impacting patient care and clinic efficiency.

The global HDx therapy enabled by Theranova studies include new data on key patient treatment measures that show stable albumin levels, significant reduction of large-middle molecules, and a statistically significant increase in health-related quality of life. Studies conducted on Baxter’s Sharesource remote patient management (telehealth) platform when used with automated PD (APD) therapy report a statistically significant reduction in patient hospitalizations and cost efficiencies.

“Realizing the best possible outcomes for dialysis patients means understanding the full potential of emerging technologies and therapies, then balancing them with good clinical management,” said Colin Hutchison, M.D., Medical Director at Hawke’s Bay District Health Board, New Zealand, and author of two HDx abstracts presented at Kidney Week. “My ongoing research with HDx therapy is helping me and other nephrologists make well-informed decisions about how to evolve treatment for our patients.”

Growing Clinical Data on HDx Therapy
Baxter’s HDx therapy enabled by Theranova was designed to filter a wider range of molecules from the blood compared to conventional hemodialysis filters, including mid-sized molecular weight uremic toxins that may be associated with inflammation and cardiovascular health for end-stage renal disease (ESRD) patients1, 2, 3. By extending the range of molecules that can be filtered from the blood, HDx results in a clearance profile that more closely mimics the natural kidney4, 5.

In Dr. Hutchison’s first study, he examined the safety and efficacy of HDx therapy over six months (Abstract #TH-PO353). The primary outcome indicated a clinically insignificant change (2.9 percent) in albumin levels from the start of the study through six months. Albumin is one of the most important proteins in the body, and a lower serum albumin level has been associated with mortality6 . A sustained, unexplained reduction in albumin (>25%) was not observed in any participant, and secondary outcomes indicated functional and nutritional assessments were stable. The study was a single-arm, multi-center device study that included 87 chronic patients; Dr. Hutchison plans additional studies to assess the full impact of HDx on long-term patient outcomes.

In a second study assessing albumin levels of chronic patients on HDx therapy (Abstract #SA-PO900), Dr. Hutchison found HDx therapy did not result in significant change in pre-dialysis serum albumin concentrations over six months. Of interest, the study also reported 50 percent of the population received a reduced dose of erythropoietin, which most dialysis patients receive to combat anemia.

Additional HDx data presented included a health-related quality of life study that found about a 50 percent reduction in the diagnosis of restless leg syndrome, a common problem for dialysis patients that results in uncomfortable feelings in their legs (Abstract #TH-PO296). The study involved 666 patients over six months and was conducted across 12 Baxter clinics in Colombia. Another six-month study from Italy provided data that HDx may reduce pre-dialysis levels of middle molecules and the inflammation marker C-reactive protein, with effects becoming apparent after three months of treatment (Abstract #TH-PO357).

New Data on Telehealth Platform for PD
Sharesource allows healthcare providers to securely view their patients’ recently completed home dialysis-related treatment data that is automatically collected after each PD session. Healthcare providers can then act on this information by remotely adjusting their patients’ home device settings without requiring them to make additional trips to the clinic.

New data on remote patient management indicated statistically significant reduced hospitalization for home patients using Baxter’s Sharesource telehealth platform with an APD system (Abstract #FR-PO683). While many factors contribute to these findings, it is believed remote patient management technology helps support greater communication between patients and their healthcare providers, which can improve adherence to treatment and identify potential complications before they become serious. The retrospective study evaluated 90 patients using remote patient management with an APD system, in comparison to 864 patients without the telehealth technology across 46 Baxter clinics in Colombia.

A second study on remote patient management used an analytical model to estimate how the telehealth platform may impact overall health system costs for PD care in Colombia (Abstract #FR-PO685). The model was based on retrospective data pulled from patient-level registries and medical records and included rates of hospitalization, peritonitis, technique failure and mortality. In the model, remote patient management generated overall savings of approximately $16,000 USD per patient; avoided 25 hospitalization episodes and 243 hospital days; and prevented 17 peritonitis episodes, among others. A sensitivity analysis showed that the model had a 66 percent accuracy rate.

To read the full abstracts for these and other HDx and remote patient management studies presented during Kidney Week, please refer to the Journal of the American Society of Nephrology: Kidney Week Edition.

HDx enabled by Theranova is available in Asia, Canada, Europe and select Latin America markets. Theranova is an investigational device in the United States, and is not available for commercial sale in that market.

The Sharesource remote patient management platform is available with the Amia APD system in the United States and Canada, and is currently being used by more than 5,000 ESRD patients to manage therapy. Sharesource is also available outside the United States with Baxter’s HomeChoice Claria APD system in Asia, Europe and Latin America, and with the Kaguya APD system in Japan.

About Baxter
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.

Rx Only. For safe and proper use of the devices mentioned herein, refer to the Theranova Instructions for Use.

This release includes forward-looking statements concerning HDx enabled by Theranova, one of Baxter’s dialysis membranes, and Sharesource remote patient management including expectations regarding 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, Theranova, Sharesource, Amia, HomeChoice Claria and Kaguya are registered trademarks of Baxter International Inc.

1 Wolley et al. Exploring the Clinical Relevance of Providing Increased Removal of Large Middle Molecules. Clin J Am Soc Nephrol. 2018;13:805-814.
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 Kirsch AH, et al. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017;32:165-172.
6 Mehrotra R1, Duong U, Jiwakanon S, Kovesdy CP, Moran J, Kopple JD, Kalantar-Zadeh K Serum albumin as a predictor of mortality in peritoneal dialysis: comparisons with hemodialysis. Am J Kidney Dis. (2011) 58:418-28.

SOURCE: Baxter International Inc.