Studies a kidney test in adults with diabetes and chronic kidney disease
Looks at how a kidney test affects care for adults with diabetic kidney disease.
Plain-language title generated from the registry record
Registry title: Real World Evidence Clinical Utility Study of KidneyIntelX
Key facts
- Where
- New York, United StatesSee the site
Where in United States
- Mount Sinai Health SystemNew York, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Renalytix AI, Inc.
- Trial code
- NCT04802395
- Record updated
- 13 August 2026
- Original description
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.Read full original descriptionShow less
Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease
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.
Inclusion: Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.
Exclusion: Patients who are currently on Enbrel; Patients with eGFR <30 or ≥ 60 ml/min/1.73m2 without albuminuria; Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population; 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.