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
Renalytix AI, Inc.
10,000 participants
Mar 2, 2021
OBSERVATIONAL
Conditions
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 Criteria1
- Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.
Exclusion Criteria7
- 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.
Interventions
KidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function 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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04802395