Status:
ACTIVE_NOT_RECRUITING
Prospective Decision Impact Clinical Utility Trial of KidneyIntelX
Lead Sponsor:
Renalytix AI, Inc.
Conditions:
Diabetic Kidney Disease
Chronic Kidney Diseases
Eligibility:
All Genders
23+ years
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT05198284
Start Date
November 1 2021
End Date
November 1 2026
Last Update
April 12 2024
Active Locations (1)
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1
Mount Sinai Health System
New York, New York, United States, 10029