RecruitingNCT04791358

Decision Impact Trial of KidneyIntelX

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


Sponsor

Renalytix AI, Inc.

Enrollment

1,500 participants

Start Date

Nov 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 23 Years

Plain Language Summary

Simplified for easier understanding

This trial is evaluating whether a kidney risk score called KidneyIntelX — a blood test that uses biomarkers to predict how fast kidney disease will progress — actually changes how doctors manage patients with Type 2 diabetes and early-stage diabetic kidney disease (DKD). Researchers want to know if having this test result leads to better or more aggressive care. **You may be eligible if...** - You are 23 or older - You have Type 2 diabetes - You have early-to-moderate diabetic kidney disease (eGFR 30–60, or eGFR over 60 with significant protein in your urine) - Relevant blood and urine tests are available or can be performed **You may NOT be eligible if...** - You do not have Type 2 diabetes - Your kidney disease is more advanced (eGFR below 30) - You do not have evidence of diabetic kidney disease 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 and kidney failure 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)

Delmar Family Medicine

Slingerlands, New York, United States

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NCT04791358


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