Real World Evidence Clinical Utility Study of KidneyIntelX

Chronic Kidney Diseases Clinical Trial

Official title:

Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04802395
• Other study ID #: RAI 19-1004
• Status: Recruiting
• Start date: March 2, 2021
• Est. completion date: December 1, 2026

Study information

• Verified date: April 2024
• Source: Renalytix AI, Inc.
• Contact: Roger Tun
• Phone: 646-397-3970
• Email: rtun[@]renalytix.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 1, 2026
• Est. primary completion date: December 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• KidneyIntelX
KidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function 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

Country	Name	City	State
United States	Mount Sinai Health System	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Renalytix AI, Inc.	Mount Sinai Hospital, New York

Country where clinical trial is conducted

United States, 

Outcome

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