Genetic Testing Improves CKD Diagnosis & Management: RenaCARE Study

Chronic kidney disease (CKD) affects more than 37 million adults in the United States, representing approximately 1 in 7 adults, and represents a growing global health concern. The condition places a significant burden on healthcare systems, accounting for $85.4 billion in Medicare spending in 2020, or 23.5% of total Medicare expenditures. Increasingly, genetic testing is being recognized as a valuable tool in the diagnosis and management of CKD, and recent research continues to demonstrate its clinical utility.

Genetic Testing Improves Diagnosis and Management

A recent study, RenaCARE (Renasight Clinical Application, Review, and Evaluation), assessed the impact of genetic testing on patients with CKD. The prospective, multicenter study enrolled 1,623 patients with CKD across 31 community and academic medical centers. Participants were tested using Renasight, a 385-gene kidney genetic test developed by Natera, Inc.

Initial results from RenaCARE, published in the Journal of the American Society of Nephrology in November 2023, showed that approximately 20.8% of patients with CKD had a positive genetic finding. Among those with positive results, nearly half (48%) received a new or reclassified diagnosis, and one-third (32.9%) experienced a change in their treatment plan. These findings suggest that genetic testing can significantly refine the diagnostic process and guide more personalized treatment strategies.

Follow-up Analysis Confirms Benefits

Further analysis of the RenaCARE study, focusing on data collected one year after genetic testing, has reinforced these initial findings. The analysis included 1,174 patients with CKD and assessed the impact of genetic testing on clinical management and prognosis. Researchers found that genetic testing led to a change in management in 86% of patients with a positive test result, and even in 42% of those with a negative result.

Importantly, genetic testing also influenced physicians’ estimations of a patient’s five-year prognosis. A change in prognosis was reported for 55% of patients with a positive genetic finding and 18% of those with a negative finding. This suggests that identifying the underlying genetic cause of CKD, or ruling out a genetic component, can provide clinicians with a more accurate understanding of a patient’s long-term outlook.

The Role of Renasight

The Renasight test, used in the RenaCARE study, analyzes 385 genes associated with kidney disease. The study authors concluded that the results “demonstrated that genetic testing was helpful in the clinical management and estimated prognosis of patients with CKD.” This supports the growing consensus that genetic testing should be more widely adopted in the evaluation of CKD patients.

The increasing recognition of the role of genetics in CKD is driven by the limitations of traditional diagnostic methods. Current standard of care relies on basic measurements of kidney function, imaging, and kidney biopsies, which can often fail to identify the underlying cause of the disease. Genetic testing offers a way to address these limitations by pinpointing the root of the problem, enabling more accurate diagnoses and tailored treatment plans.

Implications for Patient Care

The RenaCARE study highlights the potential for genetic testing to improve outcomes for individuals living with CKD. By identifying a genetic cause for the disease, clinicians can move beyond symptomatic treatment and address the underlying driver of kidney dysfunction. This can lead to more effective therapies, improved disease management, and a more accurate understanding of a patient’s long-term prognosis.

As of December 11, 2025, Natera, Inc. Shared the updated results from RenaCARE, emphasizing the significant impact of genetic testing on both diagnosis and management in CKD. The study’s findings are representative of the evolving understanding of genetic contributions to CKD and can potentially increase the diagnostic and clinical utility of genetic testing in at-risk populations.

While the RenaCARE study provides compelling evidence for the benefits of genetic testing in CKD, it’s important to note that it was a single-arm, interventional, prospective study. Further research, including randomized controlled trials, may be needed to fully elucidate the long-term impact of genetic testing on patient outcomes. However, the current evidence strongly suggests that genetic testing is a valuable tool for improving the care of individuals with chronic kidney disease.