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BiologicTx® Announces Initiation Of Observational Clinical Study For Regional Kidney Paired Donation Using Desensitization

Outcome Intended To Demonstrate Improvement in Overall Rate Of Kidney Transplantation in Sensitized Patients

BiologicTx Company Logo. (PRNewsFoto/BiologicTx) (PRNewsFoto/) (PRNewsFoto/BiologicTx)

News provided by

BiologicTx

May 13, 2014, 10:33 ET

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TOTOWA, N.J., May 13, 2014 /PRNewswire/ -- BiologicTx® today announced the initiation of an observational clinical study to determine if a combination of desensitization and enrollment in a regional paired donor kidney (KPD) exchange program improves the overall rate of kidney transplantation in sensitized patients.  This study is being conducted at five transplant centers in the Northwest region of the United States including:  Swedish Medical Center, the University of Washington, Virginia Mason Medical Center, Oregon Health and Science University, and Providence Sacred Heart Medical Center and Children's Hospital and is sponsored by BiologicTx®.

The desensitization and KPD study is designed to determine the following:

  • The rate of kidney transplants in sensitized patients following desensitization and enrollment in a paired donor exchange program
  • The overall number of kidney transplants per center
  • The overall number of KPD matches in the region
  • Donor types (direct, paired exchange, and altruistic)
  • The overall number of KPD exchange recipients transplanted in the region

The study is led by Dr. Lisa Florence, Principal Investigator and Director of Kidney Transplant at Swedish Medical Center.  It began enrollment in January 2014 and will operate for 24 months with a target enrollment of 100 transplant donor/recipient pairs.

"There are over 100,000 people currently on the OPTN/UNOS kidney transplant waiting list in the United States.  Most of these patients will be on this list for at least four years," said Sal Rafanelli, RPh, Chief Executive Officer, and Co-Founder of BiologicTx.  "We are confident that by desensitizing patients prior to transplant, we can facilitate a greater number of successful transplants and reduce their wait time."

For additional information on the KPD desensitization clinical study, please visit www.clinicaltrials.gov, Identification Number:  NCT01896089.

About Desensitization
Desensitization is a process that removes harmful antibodies from the bloodstream.  These antibodies, which fight foreign tissue like those found on a donated organ, can cause rejection of the transplanted organ.  Desensitization therapy is an IV infusion of immunoglobulin intended to reduce the recipient's sensitivity to a donor's antibodies.  Through multiple infusions prior to transplant surgery, desensitization adds helpful antibodies into the bloodstream, reducing the risk of rejecting the transplanted organ.

About BiologicTx®
BiologicTx® was founded as the first, solely focused infusion and pharmacy provider of biologic and oral transplant therapy management.  Our team is comprised of dedicated professionals that strive to advance desensitization, immunosuppressive, and rejection treatments worldwide, resulting in progressive and favorable patient outcomes.  We deliver efficient, start to finish services that establish therapeutic services in the home and clinic.  These services act in concert with the transplant center medical team.  In doing so, we provide hope and a better quality of life to our patients.  For more information, visit us at: www.BiologicTx.com.

Media Contact:

Tara Marchese


Tel: 877-567-8087


Email: [email protected]

Logo - http://photos.prnewswire.com/prnh/20130520/LA16505LOGO

SOURCE BiologicTx

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