An ever-growing body of evidence.

1. Real-World Evidence and Clinical Utility of KidneyIntelX on Patients with Early-Stage DKD

Who: The study was conducted in collaboration with the Mount Sinai Health System’s Population Health Ambulatory Pharmacy and Condition Management programs and included 1,686 patients seen by 75 providers at 20 clinical sites. The majority of patients were being treated by their primary care doctor.What: Will integrating an easily interpretable, accurate prognostic tool (KidneyIntelX) that assigns a risk score for progressive decline in kidney function, enable providers to act earlier to slow or stop the progression to kidney failure? Will the KidneyIntelX test result in changed clinical decision making for patients in the early stages of DKD?

(Note: Prediction of risk for kidney disease progression in early-stage DKD is often not assessed at the primary care level, resulting in more than 50,000 individuals per year with diabetes progressing to kidney failure, dialysis or a kidney transplant.)

Where: Published in Primary Care and Community Health, a peer-reviewed, open access journal which focuses on the study, practice, impact and outcomes of primary care services and community health programs.

Protocol: 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:

Increased follow-up and patient engagement.

• 71% of patients with high-risk scores had a clinical encounter within the first month. (vs. Standard of Care q12m)

Appropriate improvements in pharmacy management.

• 57% of high-risk patients had action taken (medication change or referral) within 3-months, compared to 35% for low-risk patients.
• Medication changes included introducing SGLT2 inhibitors to manage type 2 diabetes and CKD as well as adjustments for ACEi/ARBs to manage hypertension.

Improved control of Type 2 Diabetes.

• The study showed a 10% improvement in HbA1c levels in the first six months.
• This is most likely the result of increased patient engagement combined with appropriate medication changes including the introduction of SGLT2 inhibitors.

Improved control of chronic kidney disease.

• At the 6-month data mark, there was a 15% improvement in albuminuria, an important indicator of overall kidney health, in the low and intermediate risk groups (While other metrics such as eGFR and systolic blood pressure (SBP) remained unchanged)

2. Therapeutic Integration of KidneyIntelX with Early Stages of Diabetic Kidney Disease (DKD)

Who: 1,325 type 2 diabetes patients with DKD from 24 countriesWhat: Study goals were to (1) demonstrate that baseline KidneyIntelX assessment provides reliable risk stratification for kidney outcomes in a multi-national population; (2) to assess the impact of canagliflozin versus placebo in patients within risk strata of KidneyIntelX risk; (3) to assess the impact of SGLT2i treatment on changes in longitudinal KidneyIntelX risk scores over time; and (4) to determine the added value of early longitudinal changes in KidneyIntelX for forecasting subsequent kidney outcomes (i.e., progressive DKD).

Where: Published in the American Journal of Nephrology, a peer-reviewed journal that focuses on timely topics in both basic science and clinical research.

Protocol: Multicenter, double-blinded, placebo-controlled, randomized trials (CANVAS and CANVAS-R) done to assess the effect of canagliflozin on primarily cardiovascular events, kidney function, and safety outcomes. Participants assigned to treatment with canagliflozin or placebo were followed for a median of 6.1 years.

Results: KidneyIntelX successfully risk stratified a large multinational external cohort for progression of DKD

• The risk for progression of diabetic kidney disease for those scored as high-risk on KidneyIntelX was 8-fold greater vs those that scored as low risk
• Individuals with higher baseline KidneyIntelX risk scores derived greater numerical differences in long-term eGFR slope with treatment with canagliflozin versus placebo (0.66, 1.52, and 2.16 mL/min/1.73m² in the low, intermediate, and high KidneyIntelX risk strata, respectively).
• Canagliflozin treatment reduced KidneyIntelX risk scores over time, and changes in the KidneyIntelX score from baseline to 1 year associated with future risk of DKD progression, independent of baseline risk score and treatment arm

3. Clinical utility and clinical implementation of the KidneyIntelX prognostic tool

What: Demonstrate the decision-making impact (demand for test, adoption and clinical utility) of the risk-assessment, prognostic tool, KidneyIntelX, in the management of DKD among primary care physicians (PCPs).

Where: Published in the American Journal of Managed Care.

Protocol: There was a prospective web-based survey administered among PCPs across the United States. Conjoint analysis with multivariable logit models were used to estimate PCP preferences. The survey included hypothetical patient profiles with 6 attributes” albuminuria, eGFR, age, blood pressure, glycated hemoglobin A1c (HbA1c) and KidneyIntelX result. Each PCP viewed 8 patient profiles randomly selected from 42 unique profiles having 1 level from each attribute.

For each patient, PCPs were asked to indicate whether they would prescribe a sodium-glucose cotransporter-2 (SGLT2) inhibitor, increase angiotensin receptor blocker (ARB) dose and/or refer to a nephrologist.

Specific Results:

There was unprecedented behavior change demonstrated among PCPs: adoption, clinical utility and clinical application. The KidneyIntelX test had greater relative importance than albuminuria and eGFR to PCPs in making treatment decisions and was second only to eGFR for referring to nephrologists.

• A total of 401 PCPs completed the survey, with a response rate of 8.8%.
• The relative importance of the top 2 attributes for each decision were HBA1c (52%) and KidneyIntelX result ( 23%) for prescribing SGLT2 inhibitors; BP (62%) and KidneyIntelX results (13%) for increasing ARB dose and eGFR (42%) and KidneyIntelX result (27%) for nephrologist referral.
• A high-risk KidneyIntelX result was associated with higher odds of PCPs prescribing SGLT2 inhibitors , increasing ARB dose and referring to a nephrologist

Big Takeaways:

• Demonstrated PCP demand makes the case for increasing patient access to this innovative prognostic tool
• Demonstrated that KidneyIntelX satisfies an unmet need in standard-of-care management for DKD, indicating a need for change in practice guidelines
• This Study complements data from a real-world evidence clinical utility study of 1112 adult DKD patients presented at the ADA 82nd Scientific Sessions and the European Congress of Internal Medicine. These combined results confirm the significant benefit of using KidneyIntelX in the Primary Care setting to direct care towards improving kidney health and reducing the significant financial burden associated with DKD.