Prospective Decision Impact Clinical Utility Trial of KidneyIntelX
NCT ID: NCT05198284
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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ACTIVE_NOT_RECRUITING
2000 participants
OBSERVATIONAL
2021-11-01
2026-11-01
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 a blood-based clinical diagnostic tool that assesses the risk of progressive kidney function decline in chronic kidney disease patients with type 2 diabetes.
Eligibility Criteria
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Inclusion Criteria
* Clinical history of confirmed type 2 diabetes.
* Evidence of DKD Stages 1-3:
* Baseline eGFR of 30-59 ml/min/1.73m2 (confirmed 3 months apart with at least one value within 1 year prior to enrollment)
* Individuals with eGFR ≥60 ml/min/1.73m2 and albuminuria (UACR ≥30mg/g)
* All patients will have a HbA1c, eGFR, urine albumin and urine creatinine, eGFR, available from within 12 months of enrollment (to be obtained if not clinically available prior).
* The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.
Exclusion Criteria
* 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 who are currently on Enbrel.
23 Years
ALL
No
Sponsors
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Renalytix AI, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David W Lam, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai Health System
Locations
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Mount Sinai Health System
New York, New York, United States
Countries
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Other Identifiers
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RAI 19-1002
Identifier Type: -
Identifier Source: org_study_id
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