Real World Evidence Clinical Utility Study of KidneyIntelX

Description

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.

Conditions

Chronic Kidney Diseases, Diabetic Kidney Disease

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Study Overview

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Study Details

Study overview

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.

Real World Evidence Clinical Utility Study of KidneyIntelX in Patients With Type 2 Diabetes and Chronic Kidney Disease

Real World Evidence Clinical Utility Study of KidneyIntelX

Condition
Chronic Kidney Diseases
Intervention / Treatment

-

Contacts and Locations

New York

Mount Sinai Health System, New York, New York, United States, 10029

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

  • * Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.
  • * 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.

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

2026-12-01