Introduction and Objective: The lack of precision to identify patients with early-stage diabetic kidney disease (DKD) at near-term risk for progressive decline in kidney function results in poor disease management often leading to kidney failure requiring unplanned dialysis. The KidneyIntelX is a multiplex, bioprognostic, immunoassay consisting of 3 plasma biomarkers and clinical variables that uses machine learning to generate a risk score for progressive decline in kidney function over 5-year in adults with early-stage DKD. Our objective was to assess the impact of KidneyIntelX on management and outcomes in a Health System in the real-world evidence (RWE) study. Methods: KidneyIntelX was introduced into a large metropolitan Health System via a population health-defined approved care pathway for patients with stages 1 to 3 DKD between [November 2020 to March 2022]. Decision impact on visit frequency, medication management, specialist referral, and selected lab values was assessed. We performed an interim analysis in patients through 6-months post-test date to evaluate the impact of risk level with clinical decision-making and outcomes. Results: A total of 1686 patients were enrolled in the RWE study and underwent KidneyIntelX testing and subsequent care pathway management. The median age was 68 years, 52% were female, 26% self-identified as Black, and 94% had hypertension. The median baseline eGFR was 59 ml/minute/1.73 m2, urine albumin-creatinine ratio was 69 mg/g, and HbA1c was 7.7%. After testing, a clinical encounter in the first month occurred in 13%, 43%, and 53% of low-risk, intermediate-risk, and high-risk patients, respectively and 46%, 61%, and 71% had at least 1 action taken within the first 6 months. High-risk patients were more likely to be placed on SGLT2 inhibitors (OR = 4.56; 95% CI 3.00-6.91 vs low-risk), and more likely to be referred to a specialist such as a nephrologist, endocrinologist, or dietician (OR = 2.49; 95% CI 1.53-4.01) compared to low-risk patients. Conclusions: The combination of KidneyIntelX, clinical guidelines and educational support resulted in changes in clinical management by clinicians. After testing, there was an increase in visit frequency, referrals for disease management, and introduction to guideline-recommended medications. These differed by risk category, indicating an impact of KidneyIntelX risk stratification on clinical care.

KidneyIntelXTM combines 3 plasma biomarkers with clinical variables to categorize adults with DKD stages 1-3b for risk of a progressive decline in kidney function over 5 years. We previously demonstrated that using KidneyIntelX to assess risk and guide treatment does lead to optimized medication use, lifestyle changes, and specialist referrals. We now report the one-year pre and posttest clinical impact on eGFR slope and hemoglobin A1C (HbA1c) in the Mount Sinai Health System. Among the 1087 patients with follow-up data, the median age was 69 years, 52% were women, 32% self-identified Black, baseline eGFR 59 ml/min/1.73m2, baseline HbA1c was 7.2%, and 146 (13%), 439 (40%), and 502 (46%) were scored as high, intermediate, and low risk by KidneyIntelX. In high-risk patients, median eGFR slope slowed from -5.7 ml/min/year pre-test to -2.1 ml/min/year post-test (p<0.001), and from -1.8 ml/min/year to -1.0 ml/min/year in intermediate-risk (p=0.005) (Table). The median HbA1c decreased from 8.4 to 7.7% (p<0.001) in high risk, and from 7.5 to 7.2% (p<0.001) in intermediate risk. In conclusion, deployment and risk stratification by KidneyIntelX was associated with reduced rate of kidney function decline and improved glycemic control, particularly in those scored as high risk. Disclosure J. Tokita: Other Relationship; Renalytix. C. Sinfield: None. M. J. Donovan: Employee; Renalytix. T. McNicholas: Employee; Renalytix. M. Kattan: Research Support; Novo Nordisk. Consultant; Renalytix, Verici. Research Support; Bayer Inc. D. W. Lam: None.