DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE: BAX), a global leader in renal
innovation, today announced the start of a Phase 3 clinical trial
evaluating an investigational drug that combines a citrate anticoagulant
and renal replacement solution to determine if and to what extent it
lengthens the extracorporeal circuit life in acute kidney injury
patients treated with continuous renal replacement therapy (CRRT).
Currently, there is no citrate anticoagulant approved for use in CRRT in
the United States.
The first patient has been enrolled in the clinical trial and has
received CRRT. The multi-center, prospective, randomized, controlled
clinical trial, which is expected to run through 2017, will include an
estimated 160 ICU patients in the United States and Canada. Patients
will be randomly assigned to receive either CRRT with regional citrate
anticoagulant (Prismocitrate 18) or CRRT with no anticoagulant.
Additional details of the study can be found on clinicaltrials.gov.
''One potential obstacle in delivering effective CRRT occurs when blood
flow through the circuit is slowed or completely stopped by blood
clots,'' said Farah Ali, M.D., medical director for Acute therapies at
Baxter. ''Extending the life of the extracorporeal circuit can help
patients with acute kidney injury remain on renal replacement therapy as
prescribed, while reducing potential complications that can occur when
the blood circuit needs to be replaced.''
During CRRT, blood passes through the extracorporeal (outside the body)
circuit to help clear waste products in the blood, returning it to a
normal state. This cleaned blood is then returned to the body.
Clinicians can prescribe an anticoagulant to help reduce the likelihood
of circuit clotting. When blood flow through the circuit is interrupted,
patients may not receive the prescribed dose of CRRT, which may impact
its effectiveness.1 One retrospective study estimated that
nearly one-third of patients did not receive the prescribed dose of
CRRT, and that interruptions in CRRT were most commonly due to circuit
If approved, the product will provide a standardized formulation of
renal replacement fluid combined with a citrate anticoagulant. Combining
two different drug solutions together may make it easier for healthcare
providers to administer therapy at the bedside.
Baxter’s citrate anticoagulant combined with renal replacement solution
is an investigational drug not currently approved for use in the U.S.
About Acute Kidney Injury
Acute kidney injury (AKI) is a sudden decrease in kidney function over a
period of hours to days, often the result of illness, trauma or
infection. The sudden loss of kidney function leads to the accumulation
of toxins and fluid in the blood that, if left untreated, may lead to
death. The most severe stage of AKI requires renal replacement therapy
to replace the function of healthy kidneys.
About Baxter International Inc.
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;
biosurgery 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 Baxter’s
investigational citrate anticoagulant and renal replacement solution,
including expectations regarding the availability of the drug in the
United States, 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: 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 is a registered trademark of Baxter International Inc.
1 Ashita Tolwani, M.D.
Continuous Renal-Replacement Therapy for Acute Kidney Injury. N Engl J
Med 2012; 367:2505-2514.
2 Venkataraman R, Kellum JA,
Palevsky P. Dosing patterns for continuous renal replacement therapy at
a large academic medical center in the United States. J Crit Care