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Real World Evidence Clinical Utility Study of KidneyIntelX

RECRUITINGSponsored by Renalytix AI, Inc.
Actively Recruiting
SponsorRenalytix AI, Inc.
Started2021-03-02
Est. completion2024-12-02
Eligibility
Age23 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT04802395

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.

Eligibility

Age: 23 Years+Healthy volunteers accepted
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.

Conditions3

Chronic Kidney DiseasesDiabetesDiabetic Kidney Disease

Locations1 site

Mount Sinai Health System
New York, New York, 10029

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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