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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

Who can join

Ages 23 and older · All sexes

Inclusion Criteria:

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

Exclusion Criteria:

* 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.

About the study

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.

What is being tested

• KidneyIntelX (diagnostic test)

Sponsor: Renalytix AI, Inc. · Participants: 10,000 · Started: Mar 2, 2021

Contact the study team

• Roger Tun · Phone: 646-397-3970

Official record on ClinicalTrials.gov — NCT04802395

Locations in the U.S.

Conditions

• Chronic Kidney Disease
• Diabetic Kidney Problems

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.