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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04960514
Other study ID # RAI 19-1003
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 22, 2021
Est. completion date December 1, 2026

Study information

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

Clinical Trial Summary

The current 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 December 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.

Study Design


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 Atrium Health Wake Forest Baptist - Family Medicine - Piedmont Plaza Winston-Salem North Carolina

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
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