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Prospective Decision Impact Clinical Utility Trial of KidneyIntelX

NCT05198284 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2024-04-12

No results posted yet for this study

Summary

The clinical utility trial is designed to evaluate how the results of KidneyIntelX test / platform 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
  • Chronic Kidney Diseases
  • Chronic Kidney Disease Stage 1
  • Chronic Kidney Disease Stage 2
  • Chronic Kidney Disease Stage 3

Interventions

DIAGNOSTIC_TEST

KidneyIntelX

KidneyIntelX is a blood-based clinical diagnostic tool that assesses the risk of progressive kidney function decline in chronic kidney disease patients with type 2 diabetes.

Sponsors & Collaborators

  • Renalytix AI, Inc.

    lead INDUSTRY

Principal Investigators

  • David W Lam, MD · Mount Sinai Health System

Eligibility

Min Age
23 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-12-01
Completion
2026-11-01

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 NCT05198284 on ClinicalTrials.gov