Real World Evidence Clinical Utility Study of KidneyIntelX
NCT ID: NCT04802395
Last Updated: 2024-04-12
Study Results
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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RECRUITING
10000 participants
OBSERVATIONAL
2021-03-02
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
23 Years
ALL
No
Sponsors
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Mount Sinai Hospital, New York
OTHER
Renalytix AI, Inc.
INDUSTRY
Responsible Party
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Locations
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Mount Sinai Health System
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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RAI 19-1004
Identifier Type: -
Identifier Source: org_study_id
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