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Real World Evidence Clinical Utility Study of KidneyIntelX

NCT04802395 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2024-04-12

No results posted yet for this study

Summary

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

Interventions

DIAGNOSTIC_TEST

KidneyIntelX

KidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function in patients with type 2 diabetes and existing CKD at stages 1-3 (eGFR of 30 to 59 ml/min/1.73m2, or eGFR ≥ 60 ml/min/1.73m2 and uACR ≥ 30 mg/g).

Sponsors & Collaborators

  • Mount Sinai Hospital, New York

    collaborator OTHER

  • Renalytix AI, Inc.

    lead INDUSTRY

Eligibility

Min Age
23 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2024-12-02
Completion
2026-12-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04802395 on ClinicalTrials.gov