CareDx has enrolled the first patient in the Outcomes of KidneyCare in Renal Allografts (OKRA) registry. There will be about 4,000 patients in the Brisbane, CA-based company’s registry, which is statistically powered to determine the use 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, in a release.
KidneyCare is a management tool to assist clinicians in proactive and standardized surveillance of transplant recipients to improve long-term outcomes. AlloSure is a non-invasive donor-derived cell-free DNA (dd-cfDNA) test for identifying kidney injury.
The news comes shortly after CareDx announced a partnership with Cibiltech, a French company that develops AI-based products for predictive medicine. The goal of the collaboration is to bring a new data analysis tool to the U.S. transplant market.