Prospective Decision Impact Clinical Utility Trial of KidneyIntelX

Renalytix AI

Status: Active, not recruiting

Conditions: Chronic Kidney Diseases; Chronic Kidney Disease Stage 3; Chronic Kidney Disease Stage 2; Chronic Kidney Disease Stage 1; Diabetic Kidney Disease

Treatments: Diagnostic Test: KidneyIntelX

Study type: Observational

Funder types: Industry

Identifiers

NCT05198284

RAI 19-1002

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 23+ years old

Volunteers: No Healthy Volunteers

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 <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.