NCT04802395 Real World Evidence Clinical Utility Study of KidneyIntelX
| NCT ID | NCT04802395 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Renalytix AI, Inc. |
| Condition | Chronic Kidney Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2021-03-02 |
| Primary Completion | 2024-12-02 |
Trial Parameters
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Brief 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 Criteria
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.
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