Real World Evidence Clinical Utility Study of KidneyIntelX

Part of paid clinical trials in New York, New York.

Sponsor
Renalytix AI, Inc.
Study ID
NCT04802395
Status
Recruiting
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Conditions

  • Chronic Kidney Diseases
  • Diabetic Kidney Disease

Eligibility Criteria

Sex
ALL
Age
23 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KidneyIntelX — DIAGNOSTIC_TEST
    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).

Study Details

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.

Key Dates

Start date
Mar 2, 2021
Status verified
Apr 2024
Primary completion
Dec 2, 2024
Completion
Dec 1, 2026

Study Design

Enrollment
10,000 participants (estimated)

Primary Outcome Measure

Referrals [ Time Frame: 6 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai Health SystemNew YorkNew York10029-

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By research site
Mount Sinai Health System· New York, NY

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