Real World Evidence Clinical Utility Study of KidneyIntelX

Recruiting

• Conditions: Diabetic Kidney Disease; Chronic Kidney Diseases

• Registration Number: NCT04802395
• Lead Sponsor: Renalytix AI, Inc.

Brief Summary

The purpose of this study is to assess the impact of the KidneyIntelX assay utilized as part of the current standard of care on the management of patients seen in the primary care physician's office at Mount Sinai.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-02
• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2024-12-02
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.

Exclusion Criteria

• Patents without the appropriate characteristics as identified in the KidneyIntelX intended use population.
• 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 without minimum 6 month pre-baseline KidneyIntelX medical history.
• Patients who are currently on Enbrel.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Referrals	6 Months	Proportion (target: 20%) of patients referred to a dietician, diabetologist, or nephrologist.
HbA1c	6 Months	Proportion (target: 20% increase) of patients to receive information and or advice on their individualized target of HbA1c.
Statins and or ACEi/ARB	6 Months	Proportion (target: 20% increase) of patients treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.
SGLT2/ GLP1	6 Months	Proportion (target: 20% increase) of patients treated with SGLT2 inhibitors or GLP1 agonists.

Trial Locations

Locations (1)

Mount Sinai Health System; 🇺🇸 New York, New York, United States