NCT05198284Active, not recruiting
Prospective Decision Impact Clinical Utility Trial of KidneyIntelX
A Prospective Decision Impact Clinical Utility Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
The clinical utility trial is designed to evaluate how the results of KidneyIntelX test / platform impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 5 Jan 2022
- Start date
- 1 Nov 2021
- Primary completion date
- 1 Dec 2023
- Lead sponsor
- Renalytix AI, Inc.
- NCT number
- NCT05198284
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 1 Nov 2021 to the primary completion date, 1 Dec 2023
- 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
- 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.
Who the study is looking for
- 23 years of age or older.
- Clinical history of confirmed type 2 diabetes.
- Evidence of DKD Stages 1-3:
- Baseline eGFR of 30-59 ml/min/1.73m2 (confirmed 3 months apart with at least one value within 1 year prior to enrollment)
- Individuals with eGFR ≥60 ml/min/1.73m2 and albuminuria (UACR ≥30mg/g)
- All patients will have a HbA1c, eGFR, urine albumin and urine creatinine, eGFR, available from within 12 months of enrollment (to be obtained if not clinically available prior).
- The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.
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 | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.