Decision Impact Trial of KidneyIntelX

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.

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.

Conditions2

Locations1 site

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