A Real-World Precision Medicine Program Including the KidneyIntelX Test Effectively Changes Management Decisions and Outcomes for Patients With Early-Stage Diabetic Kidney Disease

Abstract

Introduction/objective: The KidneyIntelX is a multiplex, bioprognostic, immunoassay consisting of 3 plasma biomarkers and clinical variables that uses machine learning to predict a patient's risk for a progressive decline in kidney function over 5 years. We report the 1-year pre- and post-test clinical impact on care management, eGFR slope, and A1C along with engagement of population health clinical pharmacists and patient coordinators to promote a program of sustainable kidney, metabolic, and cardiac health.

Methods: The KidneyIntelX in vitro prognostic test was previously validated for patients with type 2 diabetes and diabetic kidney disease (DKD) to predict kidney function decline within 5 years was introduced into the RWE study (NCT04802395) across the Health System as part of a population health chronic disease management program from [November 2020 to April 2023]. Pre- and post-test patients with a minimum of 12 months of follow-up post KidneyIntelX were assessed across all aspects of the program.

Results: A total of 5348 patients with DKD had a KidneyIntelX assay. The median age was 68 years old, 52% were female, 27% self-identified as Black, and 89% had hypertension. The median baseline eGFR was 62 ml/min/1.73 m², urine albumin-creatinine ratio was 54 mg/g, and A1C was 7.3%. The KidneyIntelX risk level was low in 49%, intermediate in 40%, and high in 11% of cases. New prescriptions for SGLT2i, GLP-1 RA, or referral to a specialist were noted in 19%, 33%, and 43% among low-, intermediate-, and high-risk patients, respectively. The median A1C decreased from 8.2% pre-test to 7.5% post-test in the high-risk group (P < .001). UACR levels in the intermediate-risk patients with albuminuria were reduced by 20%, and in a subgroup treated with new scripts for SGLT2i, UACR levels were lowered by approximately 50%. The median eGFR slope improved from -7.08 ml/min/1.73 m²/year to -4.27 ml/min/1.73 m²/year in high-risk patients (P = .0003), -2.65 to -1.04 in intermediate risk, and -3.26 ml/min/1.73 m²/year to +0.45 ml/min/1.73 m²/year in patients with low-risk (P < .001).

Conclusions: Deployment and risk stratification by KidneyIntelX was associated with an escalation in action taken to optimize cardio-kidney-metabolic health including medications and specialist referrals. Glycemic control and kidney function trajectories improved post-KidneyIntelX testing, with the greatest improvements observed in those scored as high-risk.

Keywords: KidneyIntelX; Real World Evidence; diabetic kidney disease; early-stage; precision medicine; treatment management.

Figure 1.

Action taken post-KidneyIntelX result stratified by level of risk. The amount of time until a medical action was initiated (ie, referral to specialty clinics, new prescriptions) post-KidneyIntelX is presented according to level of patient risk. Time to action was divided into the following periods: 30-day (pink), 60-day (teal), 3-month (dark blue), and 6-month (purple) post-test result.

Figure 2.

Occurrence of specialty referrals post-KidneyIntelX result according to risk. (a) referral to a specialist based on the KidneyIntelX risk category. Time to referral was divided into the following periods: 30-day (pink), 60-day (teal), 3-month (dark blue), and 6-month (purple) post-test result. (b) Sankey Flow diagram demonstrating proportion of referrals based on provider.

Figure 3.

New SGLT2i prescriptions post-KidneyIntelX result stratified by risk and referring physician. (a) Post-test result with all patients followed for 12 months in the high- (19%) versus low-risk (4%) KidneyIntelX groups. Time to new SGLT2i Rx was divided into the following periods: 30-day (pink), 60-day (teal), 3-month (dark blue), and 6-month (purple) post-test result. (b) The physician type most likely to order SGLT2i. Referral physicians were categorized as follows: Endocrinology (dark blue), Nephrologist (orange), and Primary Care Physician (light blue). Abbreviations: Rx, prescription; SGLT2i, sodium glucose transporter 2 inhibitors.

Figure 4.

Percent change in prescription usage pre- and post-test, stratified by level of risk. The increase in usage post-KidneyIntelX test result is primarily observed in the high- and intermediate-risk groups (red and orange, respectively). Abbreviations: GLP-1RA, glucagon-like peptide 1 receptor agonist; SGLT2i, sodium glucose transporter 2 inhibitor.

Figure 5.

Change in eGFR slope over time. The eGFR slope improved between pre- and post-test result across all risk categories (P < .001 for all). Data presented as change in eGFR slope. Low-risk (green), intermediate-risk (orange), and high-risk (red). Abbreviation: eGFR, estimated glomerular filtration rate.