NCT04802395Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 12 Mar 2021
- Start date
- 2 Mar 2021
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Renalytix AI, Inc.
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT04802395
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 2 Mar 2021 to the primary completion date, 1 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who are currently on Enbrel.
Lab values
- Patients with eGFR \<30 or ≥ 60 ml/min/1.73m2 without albuminuria.
Other
- 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.
Who the study is looking for
- Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.
Age in the registry: 23 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Health System Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.