Baxter Enrolls First Patients in U.S. and Colombia Clinical Trials for HDx Therapy Enabled by THERANOVA
October 03 2017 - 8:30AM
Business Wire
- Expanded hemodialysis (HDx) therapy
enabled by THERANOVA is designed to closely mimic the natural
kidney through clearance of small to large middle molecules during
dialysis
- Two new clinical trials will evaluate
effectiveness, safety and health-related quality of life associated
with HDx therapy enabled by THERANOVA
- THERANOVA dialyzer works with standard
hemodialysis equipment without the need for replacement fluid
Baxter International Inc. (NYSE:BAX), a global innovator in
renal care, today announced enrollment of first patients in two new
clinical trials for a unique expanded hemodialysis (HDx) therapy
enabled by THERANOVA. The U.S. trial is a multi-center,
prospective, randomized controlled study to evaluate the
effectiveness and safety of THERANOVA, which will support
submission for marketing authorization from the U.S. Food and Drug
Administration. In addition, health-related quality of life and the
potential to reduce medication use will be assessed.
Baxter’s HDx therapy enabled by THERANOVA was designed to remove
large molecular weight toxins that have been associated with
inflammation and cardiovascular health for end-stage renal disease
(ESRD) patients.1,2,3 The dialyzer is available in select countries
around the world including Colombia, where Baxter initiated a
second large multi-center, prospective, observational trial
designed to understand the impact of removing large uremic toxins
on survival and hospitalization.
“These clinical trials allow us to examine the effectiveness and
safety of THERANOVA and assess patient relevant outcomes, including
health-related quality of life measures and dialysis symptoms,”
said Dheerendra Kommala, M.D. vice president Renal Medical Affairs,
Baxter. “We are dedicated to building evidence to support this
unique innovation in hopes of improving standards of care for ESRD
patients who rely on HD to stay alive.”
Hemodialysis (HD) therapy is used to treat nearly three million
ESRD patients worldwide, and is most often performed three times a
week in a clinic. The therapy works by cleaning the blood of toxins
and removing extra fluids when it is pumped through an artificial
kidney filter or dialyzer, such as THERANOVA.
HDx therapy extends the range of molecules that can be cleared
from the blood during HD, resulting in a clearance profile that
more closely mimics the natural kidney.4 HDx therapy enabled
by THERANOVA is performed during conventional HD therapy, does not
require generation of replacement fluid and works on standard
equipment for operational efficiencies.
In a previous study published in Nephrology Dialysis
Transplantation, researchers found that HDx enabled by the
THERANOVA dialyzer can exceed the performance of other types of
dialysis, including high flux hemodialysis and high-volume
hemodiafiltration (HDF) for specific large middle molecules, with
acceptable albumin removal.5 Additionally, independent data
presented at ERA-EDTA 2017 indicated HDx therapy effectively
removed small and mid-sized toxins at similar rates when compared
to high-volume HDF using a larger hemofilter.6
“Millions of patients with chronic kidney disease rely on renal
innovations every day, many of whom have ESRD and require HD
therapy to stay alive,” said Laura Angelini, general manager,
Baxter’s Chronic Renal business. “HDx therapy enabled by
THERANOVA was designed to build on Baxter’s legacy of providing
meaningful innovations, and it is testament of our commitment to
supporting the best possible outcomes for HD patients.”
HDx enabled by THERANOVA is available in Europe, select markets
in Latin America, the Middle East and Far East, as well as in
Australia and New Zealand. It is not yet available for use in the
United States.
For prescription only. For safe and proper use of the
devices mentioned herein, refer to the THERANOVA Instructions for
Use.
About Baxter
Baxter provides a broad portfolio of essential renal and
hospital products, including home, acute and in-center dialysis;
sterile IV solutions; infusion systems and devices; parenteral
nutrition; surgery products and anesthetics; and pharmacy
automation, software and services. The company’s global footprint
and the critical nature of its products and services play a key
role in expanding access to healthcare in emerging and developed
countries. Baxter’s employees worldwide are building upon the
company’s rich heritage of medical breakthroughs to advance the
next generation of healthcare innovations that enable patient
care.
This release includes forward-looking statements concerning HDx
enabled by THERANOVA, one of Baxter’s dialysis membranes, including
expectations regarding its potential impact on patients and
anticipated 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 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 Kirsch
AH, et al. Performance of hemodialysis with novel medium cut-off
dialyzers. Nephrol Dial Transplant. 2017 ;32:165-172.6 Teatini, U
et al. A short-term report of HD treatments with the new dialyzers
Theranova, ERA-EDTA 2017, Abstract #MP538
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Baxter International Inc.Media Contact:Jill
Carey-Hargrave(224) 948-5353media@baxter.comorInvestor
Contact:Clare Trachtman(224) 948-3085
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