Prospective Decision Impact Clinical Utility Trial of KidneyIntelX

Chronic Kidney Diseases Clinical Trial

Official title:

A Prospective Decision Impact Clinical Utility Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05198284
• Other study ID #: RAI 19-1002
• Status: Active, not recruiting
• Start date: November 1, 2021
• Est. completion date: November 1, 2026

Study information

• Verified date: April 2024
• Source: Renalytix AI, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: November 1, 2026
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 1
• Chronic Kidney Disease Stage 2
• Chronic Kidney Disease Stage 3
• Chronic Kidney Diseases
• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• KidneyIntelX
KidneyIntelX is a blood-based clinical diagnostic tool that assesses the risk of progressive kidney function decline in chronic kidney disease patients with type 2 diabetes.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Renalytix AI, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Proportion (target: 20% increase from prior measurements) of visits in which each participant achieves target blood pressure of <140/90 mmHg (as per the NKF CKD management guidelines).	12 Months
Primary	HbA1c	Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c.	12 Months
Primary	ACEi/ARB	Proportion (target: 20% increase) of patients recently treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.	12 Months
Primary	SGLT2/ GLP1	Proportion (target: 20% increase) of patients recently treated with SGLT2 inhibitors or GLP1 agonists.	12 Months
Primary	Urine albumin to creatinine ratio	In those with baseline albuminuria, proportion (target: 20%) of patients achieving a 30% decrease in their urine albumin to creatinine ratio from averaged pre-enrollment values to average post-enrollment values through 1 year.	12 Months
Primary	Referrals	Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist.	12 Months