RecruitingNCT04802395

Real World Evidence Clinical Utility Study of KidneyIntelX

Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease

Sponsor

Renalytix AI, Inc.

Enrollment

10,000 participants

Start Date

Mar 2, 2021

Study Type

OBSERVATIONAL

Conditions

Chronic Kidney Diseases Diabetic Kidney Disease

Summary

The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.

Eligibility

Min Age: 23 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating how a blood test called KidneyIntelX — which predicts how quickly kidney disease will progress — affects doctors' treatment decisions and patient outcomes in real-world clinical practice for people with type 2 diabetes and kidney disease. **You may be eligible if...** - You have type 2 diabetes - You also have chronic kidney disease at a moderate stage (specific kidney function and protein levels in urine that your doctor can assess) **You may NOT be eligible if...** - Your kidney disease does not fall into the specific category the test is designed for - You have conditions that make you outside the intended use population for this test Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTKidneyIntelX

KidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function in patients with type 2 diabetes and existing CKD at stages 1-3 (eGFR of 30 to 59 ml/min/1.73m2, or eGFR ≥ 60 ml/min/1.73m2 and uACR ≥ 30 mg/g).

Locations(1)

Mount Sinai Health System

New York, New York, United States

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NCT04802395

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