Real-world data from 2,470 patients demonstrate sustained improvements in kidney function, treatment uptake, and patient risk levels.

Renalytix PLC announced results from a two-year real-world evidence study for its Food and Drug Administration (FDA)-approved kidneyintelX.dkd test. The study, published in Diabetes, Obesity and Metabolism, followed 2,470 patients with type 2 diabetes and early-stage chronic kidney disease across two US health systems.

The research, conducted at Mount Sinai Health System in New York and Wake Forest/Atrium Health in North Carolina, indicates that the test improves how clinicians assess risk and impacts the course of the disease over a 24-month period.

Two-Year Data Highlights

Prior studies showed the KidneyIntelX test influenced clinical decisions and improved immediate markers of kidney health. The two-year analysis shows these improvements translate into real and lasting benefits for patients.

  • 29% of patients who were retested moved into a lower risk category, accompanied by biomarker reductions.
  • SGLT2 inhibitor use increased substantially across all risk groups over two years, reaching 56% in high-risk patients overall and 70% in high-risk patients at Mount Sinai. Combination SGLT2 inhibitor and GLP-1 receptor agonist therapy in high-risk patients nearly tripled, rising from 12% to 32% over the same period.
  • Patients who started SGLT2i or GLP-1 RA therapies had nearly double the odds (OR 1.93) of achieving risk reduction.
  • KidneyIntelX demonstrated independent prognostic performance: patients designated as high-risk at baseline were 10.4 times more likely to experience significant kidney function decline or kidney failure than low-risk patients, even after adjusting for standard clinical variables. No standard clinical combination—eGFR, UACR, HbA1c—has achieved risk separation of this magnitude.
  • From baseline to two years, the rate of eGFR decline improved by 43%, UACR decreased by 23%, and HbA1c decreased by 7.6% in high risk patients, while systolic blood pressure remained stable across all risk groups.

“These two-year data provide the clearest real-world picture yet of what risk stratification can do when applied consistently at scale in two large health systems. What we see is that a structured, biomarker-guided approach to prescribing translates into targeted therapy decisions—higher-risk patients receiving more intensive treatment, and lower-risk patients largely spared unnecessary escalation,” says David Lam, MD, co-principal investigator and endocrinologist with the Mount Sinai Health System, in a release.

The study focused on how risk stratification informs guideline-directed medical treatment. Findings included an attenuation in the decline rate of estimated glomerular filtration rate and reductions in urine albumin-creatinine ratio.

“From a nephrology standpoint, what matters most is whether risk stratification translates into durable kidney protection—and that is what we are seeing here. The attenuation in eGFR decline rate sustained over two years, alongside reductions in UACR, reflects real change,” says Joji Tokita, MD, co-principal investigator and nephrologist with the Mount Sinai Health System, in a release.

Tokita also notes that repeat testing data showed nearly one-third of high-risk patients moved to a lower risk category at one year. This shift was linked to drops in kidney injury molecule-1 and the initiation of therapy.

The KidneyIntelX technology uses artificial intelligence and data-driven insights to help clinical teams understand patient risk for progressive decline in kidney function during the earliest stages of diabetic kidney disease. According to the company, the two-year analysis proves that earlier markers of kidney health translate into lasting benefits for patients.

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