← Back to all trials
Active Not Recruiting
NCT05198284
Prospective Decision Impact Clinical Utility Trial of KidneyIntelX
Conditions: Diabetic Kidney Disease, Chronic Kidney Diseases, Chronic Kidney Disease Stage 1, Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 3
Sex: All
Ages: 23 Years – N/A
Healthy volunteers: No
Enrollment: 2000
Sponsor: Renalytix AI, Inc.
Location: Mount Sinai Health System New York New York
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Patients with eGFR \
Source: ClinicalTrials.gov (NCT05198284). StuddyBuddy aggregates publicly available trial information.
