Study Suggests C1-INH May Aid in Prevention of Antibody-Mediated Rejection
Following Kidney Transplant
Findings presented at the 2014 World Transplant Congress
SAN FRANCISCO, July 30, 2014
SAN FRANCISCO, July 30, 2014 /PRNewswire/ -- A study presented at the 2014
World Transplant Congress evaluated the safety and efficacy of CSL Behring's
C1 Inhibitor (C1-INH) concentrate in preventing antibody-mediated rejection
following kidney transplants in highly sensitized patients. C1-INH is a human
protein and an important inhibitor of the complement system.
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The study shows that post-transplant treatment with C1-INH results in
significant increases in the levels of complement components 3 and 4,
suggesting that C1-INH inhibits activation of the complement system following
transplantation. Antibody-mediated rejection is a major cause of kidney
transplant failure and is often associated with activation of complement, a
set of proteins that work with antibodies and play a role in the development
of inflammation and tissue damage.
"Antibody-mediated rejection is a severe form of rejection that can occur in
patients who have undergone a kidney transplant," said Stanley C. Jordan,
M.D., Kidney Transplant, Cedars-Sinai Medical Center in Los Angeles, and one
of the study's investigators. "Our findings provide additional insight into
how C1-INH affects complement activation and represent an important advance in
the study of complement-targeting therapeutics."
The placebo-controlled, single-center study evaluated 20 highly sensitized
patients, meaning they already had antibodies against donor organs. Subjects
were randomized to receive either placebo or 20 IU/kg of C1-INH, administered
intra-operatively, then twice a week for seven additional doses. Patients were
desensitized with immunoglobulin and rituximab, decreasing the patient's
antibody levels prior to transplant.
According to study findings, fewer patients who were administered C1-INH
developed serious adverse events compared to those administered placebo (20
percent versus 30 percent). C1-INH function and antigen levels in blood
increased with C1-INH treatment [C1 function (p=0.0007) and C1-INH antigen
percent (p=0.013)]. Patients treated with C1-INH experienced increased C3
levels on day 30 (p=0.005), while C4 levels were significantly higher at all
time points. During the study period, no patient treated with C1-INH developed
antibody-mediated rejection. Twenty percent of patients developed
antibody-mediated rejection following the study period. Thirty percent of
patients treated with placebo developed antibody-mediated rejection, ten
percent during the study period.
This Investigator-Initiated Research study was supported by CSL Behring.
About Antibody-Mediated Rejection
Antibody-mediated rejection is a major cause of kidney transplant failure and
a prime barrier to improving long-term outcomes for transplant patients. The
types of antibody-mediated rejection vary in acuity and severity.
Approximately 10 to 15 percent of kidney recipients experience rejection
within one year after transplantation.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed
to saving lives and improving the quality of life for people with rare and
serious diseases, the company manufactures and markets a range of
plasma-derived and recombinant therapies worldwide.
CSL Behring therapies are used around the world to treat coagulation disorders
including hemophilia and von Willebrand disease, primary immune deficiencies,
hereditary angioedema and inherited respiratory disease, and neurological
disorders in certain markets. The company's products are also used in cardiac
surgery, organ transplantation, burn treatment and to prevent hemolytic
diseases in the newborn. CSL Behring is a subsidiary of CSL Limited, a
biopharmaceutical company with headquarters in Melbourne, Australia. For more
information, visit www.cslbehring.com. CSL Behring operates one of the world's
largest plasma collection networks, CSL Plasma.
SOURCE CSL Behring
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