Decision Impact Trial of KidneyIntelX

Status unconfirmed

Conditions studied: Diabetic Kidney Disease

In brief

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.

Key facts

Study ID

NCT04791358

Run by

Renalytix AI, Inc.

People needed

1500

Starts

2021-11-01

Expected to finish

2024-12-01

Last updated by the study team

2024-04-12

Who can join

Age: 23 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Delmar Family Medicine — Slingerlands, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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