Real World Evidence Clinical Utility Study of KidneyIntelX
Recruiting · NCT04802395 · Observational (researchers observe without assigning treatment) · Lead sponsor: Renalytix AI, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
KidneyIntelX
What this trial is 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.
Who can take part
Age range
23 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
2 locations listed across 1 US state.
- Mount Sinai Health System - New York, New York, United States
- Mount Sinai Health System - New York, New York, United States