Decision Impact Trial of KidneyIntelX

Description

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.

Conditions

Diabetic Kidney Disease

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Study Overview

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Study Details

Study overview

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.

A Prospective Decision Impact Trial of KidneyIntelX in Patients With Type 2 Diabetes and Existing Chronic Kidney Disease

Decision Impact Trial of KidneyIntelX

Condition
Diabetic Kidney Disease
Intervention / Treatment

-

Contacts and Locations

Slingerlands

Delmar Family Medicine, Slingerlands, New York, United States, 12159

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

23 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Renalytix AI, Inc.,

Study Record Dates

2024-12-01