Prospective Decision Impact Clinical Utility Trial of KidneyIntelX

Study Overview
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Brief Summary
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The clinical utility trial is designed to evaluate how the results of KidneyIntelX test / platform impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.

Official Title
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A Prospective Decision Impact Clinical Utility Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease

Conditions
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Diabetic Kidney Disease, Chronic Kidney Diseases, Chronic Kidney Disease Stage 1, Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 3

Intervention / Treatment
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* Diagnostic Test: KidneyIntelX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 23 years of age or older. Clinical history of confirmed type 2 diabetes. Evidence of DKD Stages 1-3: Baseline eGFR of 30-59 ml/min/1.73m2 (confirmed 3 months apart with at least one value within 1 year prior to enrollment) Individuals with eGFR ≥60 ml/min/1.73m2 and albuminuria (UACR ≥30mg/g) All patients will have a HbA1c, eGFR, urine albumin and urine creatinine, eGFR, available from within 12 months of enrollment (to be obtained if not clinically available prior). The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents. Exclusion Criteria: Patients with eGFR <30 or ≥ 60 ml/min/1.73m2 without albuminuria. Patients with ESRD or on renal recovery treatments at time of enrollment. Patients who are pregnant at the time of enrollment. Patients who are currently hospitalized. Patients who are currently on Enbrel.

Ages Eligible for Study
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Minimum Age: 23 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: KidneyIntelX|KidneyIntelX is a blood-based clinical diagnostic tool that assesses the risk of progressive kidney function decline in chronic kidney disease patients with type 2 diabetes.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Proportion (target: 20% increase from prior measurements) of visits in which each participant achieves target blood pressure of <140/90 mmHg (as per the NKF CKD management guidelines). | 12 Months | 
| HbA1c | Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c. | 12 Months | 
| ACEi/ARB | Proportion (target: 20% increase) of patients recently treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers. | 12 Months | 
| SGLT2/ GLP1 | Proportion (target: 20% increase) of patients recently treated with SGLT2 inhibitors or GLP1 agonists. | 12 Months | 
| Urine albumin to creatinine ratio | In those with baseline albuminuria, proportion (target: 20%) of patients achieving a 30% decrease in their urine albumin to creatinine ratio from averaged pre-enrollment values to average post-enrollment values through 1 year. | 12 Months | 
| Referrals | Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist. | 12 Months |