Real World Evidence Clinical Utility Study of KidneyIntelX

NCT ID: NCT04802395

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-02

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Diseases Diabetic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mount Sinai Hospital, New York

OTHER

Sponsor Role collaborator

Renalytix AI, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mount Sinai Health System

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Roger Tun

Role: CONTACT

646-397-3970 ext. 106

Other Identifiers

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RAI 19-1004

Identifier Type: -

Identifier Source: org_study_id

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