Natera has announced full enrolment for the RenaCARE (Renasight Clinical Application, Review and Evaluation) study—a real-world, prospective, multicentre trial to assess the clinical utility of Natera’s Renasight genetic testing panel, which analyses more than 380 genes related to kidney disease.
Enrolment in the study was completed early as a result of statistically meaningful interim data analysis. The study includes more than 1,700 patients across 30-plus sites, representing leading academic and private nephrology clinics in the USA, according to the company. A publication for the RenaCARE study is expected to be submitted in early 2023.
The RenaCARE study aims to demonstrate how genetic findings impact the clinical management of patient care and examines outcomes of patients tested with the Renasight genetic testing panel. It will also assess patient satisfaction, health knowledge and genetic literacy. The study follows a 2019 publication in the New England Journal of Medicine showing that approximately 10% of people with chronic kidney disease (CKD) have a genetic diagnosis.
“RenaCARE is the only large-scale, prospective, multi-site study, to our knowledge, looking at the clinical utility of performing routine genetic testing on CKD patients,” said Sangeeta Bhorade, chief medical officer for organ health at Natera. “We are optimistic this study could have the potential to optimise the management of patients with CKD and ultimately improve outcomes.”
Ali Gharavi, the study’s principal investigator, serves as the chief of the Division of Nephrology at New York-Presbyterian/Columbia University Irving Medical Center (New York, USA). Gharavi is also a close collaborator with Kidney Disease: Improving Global Outcomes foundation (KDIGO) and the National Kidney Foundation (NKF), as per a Natera press release.