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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04791358
Other study ID # RAI 20-1001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date December 1, 2024

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
Health authority
Study type Observational

Clinical Trial Summary

The current trial is designed to evaluate how the results of KidneyIntelX test 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 Recruiting
Enrollment 1500
Est. completion date December 1, 2024
Est. primary completion date November 1, 2024
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 30-60 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 an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function and kidney failure 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 Delmar Family Medicine Slingerlands 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
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