Decision Impact Trial of KidneyIntelX
A Prospective Decision Impact Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease
Renalytix AI, Inc.
1,500 participants
Nov 1, 2021
OBSERVATIONAL
Conditions
Summary
The current trial is designed to evaluate how the results of KidneyIntelX test impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.
Eligibility
Inclusion Criteria7
- years of age or older.
- Clinical history of confirmed type 2 diabetes.
- Evidence of DKD Stages 1-3:
- Baseline eGFR of 30-60 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.
Exclusion Criteria5
- 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 who are currently on Enbrel.
Interventions
KidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function and kidney failure 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).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04791358