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

June 17, 2019 Off By BusinessWire
  • In total, 19 abstracts were presented on Baxter’s therapy options
  • New HDx data supports growing evidence that removing a wider range
    of molecules during dialysis may benefit patient outcomes
  • Additional data show chronic kidney disease management helps reduce
    the rate of initiation to dialysis for patients in prevention programs

DEERFIELD, Ill.–(BUSINESS WIRE)–Baxter International Inc. (NYSE:BAX), a global innovator in renal care,
showcased 19 data presentations on therapy options at the 56th
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 kidney5,6. 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 TwitterLinkedIn 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

Contacts

Media Contact
Jill Carey-Hargrave, (224) 948-5353
[email protected]

Investor Contact
Clare Trachtman, (224) 948-3020