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Monday, October 25, 2021

MEDICAL DEVICE NEWS MAGAZINE

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HomeCLINICAL TRIALS, STUDIES, DATAFirst Patient Enrolled in Landmark CareDx OKRA Registry

First Patient Enrolled in Landmark CareDx OKRA Registry

Today CareDx, Inc. announced the enrollment of the first patient in the Outcomes of KidneyCare in Renal Allografts (OKRA) registry from the University of Maryland School of Medicine.

OKRA is a multicenter, prospective, observational registry, designed to measure outcomes of kidney transplant recipients managed with KidneyCare. KidneyCare complements AlloSure to include multimodality testing with the addition of AlloMap Kidney Gene Expression Profiling and prognostic graft assessment using iBox.

“Our team is excited to be the first center to enroll patients. We moved quickly to get OKRA in place at the University of Maryland School of Medicine (UMSOM) so we can begin offering KidneyCare to our transplant patients,” said Dr. Jonathan Bromberg, MD, PhD, Professor of Surgery, Microbiology and Immunology at UMSOM. “The addition of gene expression and graft survival estimates will provide new information to expand our clinical experience,” echoed Dr. Matthew Weir, MD, Director of the Division of Nephrology, and Professor of Medicine at UMSOM.

The patient transplant registry, which will be comprised of 4,000 transplant patients, is statistically powered to determine the utility of KidneyCare and provide real world data on the use of KidneyCare and AlloSure. OKRA targets more than 50 transplant centers and will enroll 1,500 newly transplanted patients, complementing the Kidney Outcomes Allograft Registry (KOAR) with 1,500 patients, matching both arms with 1,000 control patients.

“Data on 4,000 patients provides the ultimate registry to provide clarity on the utility of AlloSure and KidneyCare, and will generate many insights that show promise in improving patient outcomes,” said Sham Dholakia, Senior Vice President of Medical Affairs at CareDx.

 

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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