Renalytix's kidneyintelX.dkd Test Shows Superior CKD Risk Prediction in Major Diabetes Care Study
Key Insights
Renalytix (search) published pivotal data in Diabetes Care showing kidneyintelX.dkd (search) significantly enhanced chronic kidney disease risk stratification across all KDIGO guideline categories in 2,954 patients from CANVAS and CREDENCE trials.
The FDA-approved test demonstrated that high-risk patients treated with SGLT2 inhibitors were twice as likely to show risk improvement compared to untreated patients at one year.
Three presentations at ASN Kidney Week 2025 highlighted real-world implementation success, with 86% of physicians reporting the test directly influenced care decisions and superior performance versus existing prediction tools.
Renalytix (search) plc announced the publication of pivotal data in Diabetes Care demonstrating that its kidneyintelX.dkd (search) test significantly improves chronic kidney disease (CKD) risk prediction and treatment guidance. The study, evaluating 2,954 patients from the landmark CANVAS and CREDENCE trials, represents the largest validation of the FDA-approved prognostic test to date.
Enhanced Risk Stratification Across Patient Populations
The published manuscript, titled "Baseline Risk and Longitudinal Changes in kidneyintelX.dkd (search) and Its Association with Kidney Outcomes in the CANVAS and CREDENCE Trials," was authored by leading nephrology and metabolism experts from the US, Europe, and Australia. The study demonstrated that kidneyintelX.dkd significantly enhanced risk stratification across all KDIGO guideline categories, delivering more accurate assessment of CKD progression risk and potential kidney failure.
Among the key findings, patients classified as moderate or high risk who were treated with frontline SGLT2 inhibitors showed a significant reduction in kidneyintelX.dkd (search) risk levels at one year. Notably, high-risk patients were twice as likely to show risk improvement compared with untreated patients, providing actionable treatment guidance for clinicians.
Expert Commentary on Precision Medicine Implementation
Associate Professor Brendon Neuen of The George Institute for Global Health, Sydney, and co-author of the study, emphasized the clinical significance of these findings. "With multiple recent breakthroughs in therapies to reduce kidney function decline, the time for risk-based implementation in CKD has arrived," Neuen commented. "Incorporating novel biomarkers, as done with kidneyintelX.dkd (search), holds strong promise to guide risk-based care."
Neuen, who serves as Program Lead, Renal & Metabolic at The George Institute and Director of Kidney Trials at Royal North Shore Hospital, added that the data provide "a compelling example of how we can build on well-established clinical parameters to deliver more personalized care and reduce the risk of adverse outcomes."
Real-World Implementation and Clinical Utility
At ASN Kidney Week 2025 in Houston, Renalytix (search) presented three abstracts highlighting the practical implementation and performance advantages of kidneyintelX.dkd (search). The presentations demonstrated scalable deployment across a major US health network and significant clinical utility in community practice settings.
In the decision-impact study conducted in community practice, 87% of patients reported better understanding of their kidney risk, while 98% said the test improved their understanding of kidney health and its importance. Critically, 86% of physicians reported that kidneyintelX.dkd (search) directly influenced their care decisions.
Superior Performance Versus Existing Tools
The third presentation at ASN Kidney Week demonstrated that kidneyintelX.dkd (search) outperformed the Kidney Failure Risk Equation (KFRE) in predicting kidney function decline or kidney failure in diabetic kidney disease. The test showed superior discrimination and reliability, particularly in early-stage disease where accurate risk assessment is most challenging.
Addressing a Global Health Crisis
The validation of kidneyintelX.dkd (search) comes as chronic kidney disease represents a worldwide public health crisis impacting 850 million individuals globally. According to the National Kidney Foundation, the condition affects more than 35 million adults in the United States, with 90% unaware they have the disease. Medicare spending on kidney disease and kidney failure exceeds $130 billion annually.
The authors concluded that kidneyintelX.dkd (search) and its novel kidney biomarkers enable clinicians to identify patients most likely to benefit from therapy, supporting personalized risk-based care and offering a powerful tool for future clinical trials. The test represents the only FDA-approved and Medicare-reimbursed prognostic test for early-stage risk assessment in chronic kidney disease.