Status:
RECRUITING
Real World Evidence Clinical Utility Study of KidneyIntelX
Lead Sponsor:
Renalytix AI, Inc.
Collaborating Sponsors:
Mount Sinai Hospital, New York
Conditions:
Chronic Kidney Diseases
Diabetic Kidney Disease
Eligibility:
All Genders
23+ years
Brief 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 a...
Eligibility Criteria
Inclusion
- Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.
Exclusion
- 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.
Key Trial Info
Start Date :
March 2 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT04802395
Start Date
March 2 2021
End Date
December 1 2026
Last Update
April 12 2024
Active Locations (1)
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1
Mount Sinai Health System
New York, New York, United States, 10029