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.
Study 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.
Eligibility
Sex
ALL
Min age
23 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Blood pressure — 12 Months 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).
HbA1c — 12 Months Proportion (target: 20% increase) of patients that achieve individualized target of HbA1c.
ACEi/ARB — 12 Months Proportion (target: 20% increase) of patients recently treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.
SGLT2/ GLP1 — 12 Months Proportion (target: 20% increase) of patients recently treated with SGLT2 inhibitors or GLP1 agonists.
Urine albumin to creatinine ratio — 12 Months 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.
Referrals — 12 Months Proportion (target: 20% increase) of patients referred/managed by a dietician, diabetologist, or nephrologist.
Trial sites (1)
Facility
City
Region
Status
Atrium Health Wake Forest Baptist - Family Medicine - Piedmont Plaza
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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