Real World Evidence Clinical Utility Study of KidneyIntelX

Renalytix AI

Status: Enrolling

Conditions: Chronic Kidney Diseases; Diabetic Kidney Disease

Treatments: Diagnostic Test: KidneyIntelX

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04802395

RAI 19-1004

Details and patient eligibility

About

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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 23+ years old

Volunteers: No Healthy Volunteers

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.