NEW YORK: Renalytix (LSE: RENX) announced that KidneyIntelXTM successfully risk-stratified adult patients with type 2 diabetes and early-stage chronic kidney disease (stages 1 through 3) for key clinical outcomes, including heart failure hospitalizations and death.
Individuals with diabetic kidney disease (DKD) are not only at risk of kidney disease progression, but also face an increased risk of heart failure and death, due to the significant interconnection of the cardiovascular, renal, and metabolic systems.
This data builds on KidneyIntelX clinically validated performance in assessing the risk for rapid progressive decline in kidney function in adult patients with DKD and was presented in an oral presentation on June 3rd at the American Diabetes Association 82nd Scientific Sessions® in New Orleans. The study was conducted using a subgroup analysis of KidneyIntelX in the multi-national CANagliflozin cardioVascular Assessment Study (CANVAS).
In the CANVAS study, the team of investigators assessed the ability for KidneyIntelX to risk-stratify adult patients with DKD for their risk of clinically meaningful endpoints. Application of KidneyIntelX to this population showed that those with high-risk KidneyIntelX scores were at a three-fold higher risk for hospitalization for heart failure (HHF), severe kidney disease progression or death. Moreover, those individuals who scored as high-risk in this study were most likely to benefit from treatment with canagliflozin vs. placebo.
“This data reinforces the benefit of KidneyIntelX in better informing primary care who treat patients with early diabetic kidney disease (stages 1 through 3). For these patients, cardiovascular disease is the most common cause of death and KidneyIntelX may be able to help drive guideline-recommended care, including therapies that reduce cardiovascular and renal risk,” said Steven G. Coca, DO, MS, Co-Founder of Renalytix. “In addition, these results show the potential of KidneyIntelX to enrich clinical trials for patients at higher risk of these complex conditions, which could improve trial efficiency for pharmaceutical companies.”
Diabetic kidney disease related metabolic conditions, including heart disease, chronic kidney disease and diabetes, are the leading causes of death worldwide and account for up to 20 million deaths in the U.S. annually.
KidneyIntelX is offered clinically as a laboratory-developed test. It has been validated in two large cohorts to accurately yield a simple-to-understand, custom risk score, predicting which adult patients with type 2 diabetes and chronic kidney disease stages 1-3 are at low, intermediate or high risk for rapid progressive decline in kidney function. KidneyIntelX is available across the country, where all patient tests are processed by a Renalytix Clinical Laboratory.
About Kidney Disease
Kidney disease is a public health epidemic affecting over 850 million people globally.1 The Centers for Disease Control and Prevention estimates that 15% of U.S. adults, or over 37 million people2, have chronic kidney disease (CKD). Nearly 95% of people with CKD are in early stages 1-33. Despite its magnitude, early-stage (1-3) CKD is underdiagnosed and undertreated, largely because it’s asymptomatic at this time in the disease. As many as 9 in 10 adults with CKD, and 2 in 5 adults with severe CKD do not know they have the condition.2
About Renalytix
Renalytix (NASDAQ: RNLX) (LSE: RENX) is an in-vitro diagnostics and laboratory services company that is the global founder and leader in the new field of bioprognosisTM for kidney health. The leadership team, with a combined 200+ years of healthcare and in-vitro diagnostic experience, has designed its KidneyIntelX laboratory-developed test to enable risk assessment for rapid progressive decline in kidney function in adult patients with T2D with early CKD stages 1-3. We believe that by understanding how disease will progress, patients and providers can take action early to improve outcomes and reduce overall health system costs. www.renalytix.com.