Trials / Recruiting
RecruitingNCT04802395
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
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 10,000 (estimated)
- Sponsor
- Renalytix AI, Inc. · Industry
- Sex
- All
- Age
- 23 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | KidneyIntelX | 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). |
Timeline
- Start date
- 2021-03-02
- Primary completion
- 2024-12-02
- Completion
- 2026-12-01
- First posted
- 2021-03-17
- Last updated
- 2024-04-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04802395. Inclusion in this directory is not an endorsement.