Renalytix plc announced late-breaking new clinical data demonstrating that KidneyIntelX in vitro prognostic use was associated with post-test actions that led to sustained improvements in both type 2 diabetes and chronic kidney disease health through 12 months. The results are from the evaluation of 2,317 patients being followed in a large real-world evidence (RWE) study in New York City. The twelve-month outcome data were presented at the American Diabetes Association (ADA) 83rd Scientific Sessions held June 23-26, 2023, in San Diego, California.
There are approximately 14 million adults with diabetic kidney disease in the U.S. and that number could more than double by the year 20602 due to rising trends in obesity and diabetes. KidneyIntelX is designed for use in patients with type 2 diabetes and stages 1-3 of kidney disease (early-stage diabetic kidney disease, DKD) to assess which patients are at low, intermediate, or high risk for a rapid progressive decline in their kidney function. Type 2 Diabetes Improvements Evidenced by Hemoglobin A1c in Higher Risk Groups: In patients classified as high risk, median A1C levels improved by 0.7%, a decrease from 8.2% (pre-test) to 7.5 (post-test) at one year (p< 0.001); median HbA1c decreased from 7.5% to 7.3% for patients in the intermediate risk group (p=0.001), and median A1C decreased from 7.1% to 7.0% in the low risk patients.
(p=0.9). These results support that the previously published improvement in A1C levels observed at six months pre and post KidneyIntelX testing, has been sustained for the full year, especially in the higher-risk patients. GFR slope is widely accepted as a clinical measure to determine the progression of chronic kidney disease (CKD).
In patients classified as high risk by KidneyIntelX, median eGFR slope improved from -7.1 (pre-test) to 4.5ml/min/1.73m2 (post-test) at one year (p=0.01), indicating a slowed progression of their disease. For patients with an intermediate risk score, median eGFR slope was stable at -1.5 (pre vs. post-test) to -1.4ml/min/1.73m2 at one year (p=0.6) while patients classified as low risk, the median eGFR slope improved from -1.9 (pre-test) to -0.28 ml/min/1.73 m2/year (p<0.01), further highlighting a need for broad engagement at both ends of the risk spectrum.
This data builds upon the RWE 6-month interim results published in the Journal of Primary Care and Community Health (November 2022) which demonstrated a reduction in the amount of urinary (albumin) protein in the low and intermediate KidneyIntelX risk groups. The authors concluded that the use and deployment of KidneyIntelX to risk stratify patients with early-stage diabetic kidney disease was associated with escalation in various actions taken to optimize cardio-metabolic-kidney health, including guideline-based pharmacy management and specialist consultation. Furthermore, glycemic control and kidney health improved post-KidneyIntelX testing, with the largest improvements observed in those scored as high-risk.
Importantly this data demonstrates that implementation of KidneyIntelX in patient care leads to improved clinician and patient engagement directed to slowing the progression of diabetic kidney disease and associated cardiovascular complications. In addition, during the ADA meetings, the Company presented validation data from a new IVD assay developed utilizing the KidneyIntelX platform. The risk score calculation was updated to incorporate the new race-free eGFR calculation, the availability of contemporary patient cohorts reflecting recent changes in care for diabetic kidney disease, and simplification of test inputs to enhance clinical adoption in the primary care setting.
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