Additional Data Support High Dose Haemodialysis as a Potentially More
Baxter International Inc. (NYSE:BAX) today announced the presentation of
clinical data supporting the safety and efficacy of the VIVIA
haemodialysis (HD) system. Results from two studies conducted in a
clinical setting showed acceptable clearance of uremic toxins and an
overall safety profile similar to that associated with conventional HD
devices. The VIVIA system, designed to deliver High Dose HD in the home,
completed the CE marking process (market approval) in Europe, December
The VIVIA haemodialysis system, which completed the CE marking process in Europe in December 2013, was designed to deliver High Dose HD therapy in the home. (Photo: Business Wire)
These data for the VIVIA HD system were shared for the first time with
the European nephrology community at the 51stCongress of the
European Renal Association and European Dialysis and Transplant
Association (ERA-EDTA), May 31 to June 3 in Amsterdam.
''We conducted the studies to evaluate the efficacy and safety of the
VIVIA HD system, which demonstrated its ability to provide acceptable
clearance of uremic toxins, safely and reliably,'' said Bruce Culleton,
M.D., vice president, renal therapeutic area lead, Baxter. ''This
research, in combination with the VIVIA HD system's patient-friendly
design features, may allow a greater number of dialysis patients suited
for home HD to access High Dose HD therapy in the home environment.''
VIVIA Clinical Studies
The first in-human study was a prospective, single arm clinical study
(Abstract #SP415) conducted in haemodialysis centres in the United
States, in which 22 patients received four HD treatments with the VIVIA
HD system every week for 10 weeks. The mean duration of each HD
treatment was 3.8 hours. A mean weekly standard measure of urea
clearance (Kt/Vurea) and dialysis adequacy, was 2.97. No
device-related serious adverse events occurred during the study. The
feasibility of multiple use of the same dialyser on the same patient was
In a second prospective, single arm clinical study (Abstract #SP431)
conducted in haemodialysis centres in Canada, 17 patients received
nocturnal HD treatments with the VIVIA HD system three times per week,
for six weeks. The mean duration of nocturnal HD treatment was 7.0
hours. The feasibility of multiple use of the same dialyser on the same
patient during long HD treatments was also established. No
device-related serious adverse events occurred during the study. Both
studies provided support of the VIVIA HD system's capability to
accurately remove excess body fluid, as shown by the strong correlation
between fluid weight removed, as measured by the VIVIA HD system, and
weight change (R2 0.97 in both studies).
A More Sustainable Therapy
Additional data presented at the congress support non-clinical
advantages for High Dose HD performed in the home, including a study
demonstrating the VIVIA HD system had a smaller carbon footprint
compared to a currently-available home HD device and to a conventional
in-centre HD device that can be used for home dialysis (Abstract
#SP440). The study used the life cycle assessment method to calculate
emissions including consumable supplies, energy and water used during
treatment, people transportation and waste disposal. Due in part to
multiple uses of its dialyser and blood set, the VIVIA HD system
generated the lowest amount of carbon emissions. These results suggest
optimizing the use of consumables will have a significant impact in
delivering sustainable HD therapies.
The VIVIA HD system is being introduced on a limited basis in select
European dialysis clinics in 2014 to allow patients and healthcare
providers experience with the system and its patient-friendly features.
A More Cost-Effective Therapy
Other studies included analyses on cost effectiveness and cost savings
attributable to High Dose HD at home. A review of the scientific
literature found High Dose HD at home to be either cost saving or cost
effective compared to conventional in-centre HD, while High Dose
in-centre was not cost effective (Abstract #MP562). Two separate
analyses of High Dose HD in the U.K. demonstrated that increased usage
could lead to potential cost savings (Abstract #SP615) and an increase
in quality-adjusted, life-years gained (Abstract #SP607).
ERA-EDTA presentations may be available on the congress website
following the conclusion of the meeting. For more information, log on toera-edta2014.era-edta.org.
About High Dose HD
An estimated 1.9 million end-stage renal disease (ESRD) patients
worldwide undergo haemodialysis, with the vast majority receiving
conventional haemodialysis (CHD), which is usually performed three times
a week for three to five hours per session in a centre or clinic1.
High Dose HD therapy is a more frequent therapy usually performed as
short daily treatments at least five days per week for sessions that
typically run less than four hours, or as nocturnal treatments where
sessions are conducted for greater than six hours while the patient
sleeps with no consecutive days off from therapy2. High Dose
HD therapy has been associated with improvements in survival and
clinically important health measures, including health-related quality
of life, compared with CHD3,4,5,6 .
Baxter International Inc., through its subsidiaries, develops,
manufactures and markets products that save and sustain the lives of
people with hemophilia, immune disorders, cancer, infectious diseases,
kidney disease, trauma and other chronic and acute medical conditions.
As a global, diversified healthcare company, Baxter applies a unique
combination of expertise in medical devices, pharmaceuticals and
biotechnology to create products that advance patient care worldwide.
This release includes forward-looking statements concerning Baxter's
VIVIA HD system, including expectations regarding the planned launch of
VIVIA and its use by patients. 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: actions of regulatory bodies and other governmental
authorities; satisfaction of regulatory and other requirements; product
quality or patient safety issues; changes in laws 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 VIVIA are trademarks of Baxter International Inc.
1 Anand S, Bitton A, Gaziano T (2013) The Gap between
Estimated Incidence of End-Stage Renal Disease and Use of Therapy. PLoS
ONE 8(8): e72860. doi: 10.1371/journal.pone.0072860.
2 Honkanen E, Hazel I, Zimmerman D. High-dose hemodialysis:
time for a change. Hemodial Int. 2014;18:3-6
3 Pauly RP, Gill JS, Rose CL, et al. Survival among nocturnal
home haemodialysis patients compared to kidney transplant recipients. Nephrol
Dial Transplant. 2009;24(9):2915-2919.
4 Chertow GM, Levin NW, Beck GJ; FHN Trial Group. In-center
hemodialysis six times per week versus three times per week. N Engl J
5 Nesrallah GE, Lindsay RM, Cuerden MS, et al. Intensive
hemodialysis associates with improved survival compared with
conventional hemodialysis. J AM Soc Neprol. 2012 April; 23(4):
696-705. doi: 10.1681/ASN.2011070676
6 Culleton B, et al. Effect of frequent nocturnal
hemodialysis vs conventional hemodialysis on left ventricular mass and
quality of life. JAMA 2007; 298 (11) 1291-1299.
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Source: Baxter International Inc.