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).
Study 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.
Eligibility
Sex
ALL
Min age
23 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Referrals — 6 Months Proportion (target: 20%) of patients referred to a dietician, diabetologist, or nephrologist.
Statins and or ACEi/ARB — 6 Months Proportion (target: 20% increase) of patients treated with statins and or angiotensin-converting-enzyme inhibitors and angiotensin II receptor blockers.
HbA1c — 6 Months Proportion (target: 20% increase) of patients to receive information and or advice on their individualized target of HbA1c.
SGLT2/ GLP1 — 6 Months Proportion (target: 20% increase) of patients treated with SGLT2 inhibitors or GLP1 agonists.
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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