Actively Recruiting

Age: 23Years +
All Genders
NCT04802395

Real World Evidence Clinical Utility Study of KidneyIntelX

Led by Renalytix AI, Inc. · Updated on 2024-04-12

10000

Participants Needed

1

Research Sites

300 weeks

Total Duration

On this page

Sponsors

R

Renalytix AI, Inc.

Lead Sponsor

M

Mount Sinai Hospital, New York

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Real World Evidence Clinical Utility Study of KidneyIntelX

Who Can Participate

Age: 23Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals with Type 2 diabetes and concurrent chronic (diabetic) kidney disease (G3a-G3b or G1-G2, A2-A3) per KDIGO CKD staging.
Not Eligible

You will not qualify if you...

  • Patients without the appropriate characteristics as identified in the KidneyIntelX intended use population.
  • Patients with eGFR <30 or 260 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mount Sinai Health System

New York, New York, United States, 10029

Actively Recruiting

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Research Team

R

Roger Tun

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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