Baxter Highlights Renal Care Data about Patients’ Health-Related, Quality of Life Outcomes at the 56th ERA-EDTA Congress

DEERFIELD, Ill.--(BUSINESS WIRE)-- Baxter International, Inc. (NYSE:BAX), a global innovator in renal care, showcased 19 data presentations on therapy options at the 56^th ERA-EDTA Congress, Budapest, Hungary, June 13-16. The presentations spanned the renal care continuum, from chronic kidney disease (CKD) management to peritoneal dialysis (PD) and hemodialysis (HD). This included five independent studies conducted on HDx (expanded hemodialysis) that further advance growing evidence for the therapy.

Highlighted among the HDx presentations is a new study showing improvement in quality-of-life outcomes (KDQOL 36) in physical role and functioning for maintenance HD patients [Abstract SUO011], including a significant reduction in chronic itching that is a common complication for patients. The independent, randomized controlled trial included 50 HD patients using high-flux dialyzers for more than three months who were then assigned to either stay on high-flux HD or move to HDx. Patients were evaluated at baseline and three months after randomization.

“A good measure of how any chronic patient will do on therapy is often tied to health-related quality of life measures,” says Jang-Hee Cho, M.D., Ph.D., associate professor, Kyungpook National University Hospital, Daegu, Korea. “As physicians, it should be our constant quest to seek therapy options that not only maintain a patient’s life, but also allow them to have a quality life with limited symptoms or burdens from their therapy.”

The new data is in addition to recent findings from a large observational study, which showed improvement in symptoms, effects and burden of kidney disease KDQOL 36 measures, including a 50% reduction in patients who met Restless Leg Syndrome criteria after six months on HDx therapy¹. Additional recent studies also show some patients experience reduced pre-dialysis levels of uremic toxins – toxin levels closer to what is experienced by patients with functioning kidneys – after three and six months on HDx therapy using the Theranova dialyzer².

HDx enabled by Theranova is a unique type of HD therapy that targets the removal of large middle molecules³, many of which are linked to the development of inflammation, cardiovascular disease, and other co-morbidities in dialysis patients⁴. 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 kidney^5,6. HDx enabled by the Theranova dialyzer is available in Canada and select European, Latin American and Asian markets, and is currently an investigational device in the United States.

The Continuum of Renal Care Starts with Chronic Kidney Disease Management

A more robust area of study by global researchers at this year’s ERA-EDTA included a closer look at the value of CKD management, or nephroprotection, for patients who are progressing to end-stage renal disease (ESRD), but do not yet require dialysis. One study followed a cohort of 2,445 patients for a year, monitoring their progression while in a proactive CKD management program in Colombia [Abstract FP371]. The study specifically tracked the pattern of change in patients’ creatinine levels, an indicator of kidney function. The patients in the program presented a 25% rate of initiation of dialysis therapy in a year’s time, reflecting a low median rate of kidney disease progression and a small proportion of dropout from the program.

“With an estimated 4 million ESRD patients globally and millions more going undiagnosed, we know CKD management is key to reaching more underserved patients in diverse geographies and slowing the disease progression globally,” says Laura Angelini, general manager, Baxter’s Renal Care business. “We are committed to transforming renal care across the continuum; before dialysis is required and with leading innovations that focus on patients’ quality of life and outcomes when dialysis is needed.”

Additional data presentations showcasing renal care across the therapy continuum – CKD management, PD and HD – that highlighted Baxter innovations included:

• The Real-Life Study on Expanded Hemodialysis (HDx): 9-Months Experience of a Single Hemodialysis Unit: Abstract FP539
• Comparison of the removal of uremic toxins with medium cut-off and high-flux dialyzers: a randomized clinical trial: Abstract FP528
• Factors Associated with Vascular Access Failure in Hemodialysis Patients in Colombia: FP665
• Qualitative Study About Perception of Remote Monitoring Technology for Automated Peritoneal Dialysis in Healthcare Professionals in Colombia: Abstract SP520
• Medium Cut-Off (Theranova) Dialyzer Reduces the Number of Infections in Hemodialysis Patients: A Prospective, Cross-Over Study: Abstract SP464
• Improvement of the First Year’s Cardiothoracic Ratio in Incident Dialysis Patients Associated with Better Survival: Abstract FP702

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 complete instructions in the Operator’s Manual.

This release includes forward-looking statements concerning Theranova, including potential benefits associated with its 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 and Theranova are registered trademarks of Baxter International Inc.

¹ Sanabria M et al. Quality of life reported by patients with expanded hemodialysis by the Theranova dialyzer in RTS Colombia. ASN 2018 Kidney Week Abstract TH-PO296

² Cantaluppi V et al. Removal of large-middle molecules on expanded hemodialysis (HDx): a multicentric observational study of 6 months follow-up. ASN 2018 Kidney Week Abstract TH-PO357

³ Ronco C, et al. The rise of Expanded Hemodialysis. Blood Purif 2017; 44:1—VIII

⁴ Hutchison CA, et al. The Rationale for Expanded Hemodialysis Therapy (HDx). Contrib Nephrol 2017; 191:142-52

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

⁶ Kirsch AH, et al. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017;32:165-172

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