Real World Evidence Clinical Utility Study of KidneyIntelX

ID#: NCT04802395

Age: 23 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: March 02, 2021

End Date: December 01, 2026

Contact Information:
Roger Tun
646-397-3970
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:

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.