Real World Evidence Clinical Utility Study of KidneyIntelX

Recruiting now

Conditions studied: Chronic Kidney Diseases, Diabetic Kidney Disease

In brief

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.

Key facts

Study ID

NCT04802395

Run by

Renalytix AI, Inc.

People needed

10000

Starts

2021-03-02

Expected to finish

2026-12-01

Last updated by the study team

2024-04-12

Who can join

Age: 23 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.

You may not qualify if…

• Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population.
• 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 without minimum 6 month pre-baseline KidneyIntelX medical history.
• Patients who are currently on Enbrel.

Where it is running

• Mount Sinai Health System — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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