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Prospective Decision Impact Clinical Utility Trial of KidneyIntelX
NCT05198284 · View on ClinicalTrials.gov ↗
Study Summary
The clinical utility trial is designed to evaluate how the results of KidneyIntelX test / platform impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST KidneyIntelX
Study Locations (1)
New York
- Mount Sinai Health System — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2026-11-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05198284
The ClinicalTrials.gov registry entry for NCT05198284 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Renalytix AI, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Chronic Kidney Diseases appearing as the primary indexed condition, and to 1 intervention — of which KidneyIntelX is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05198284 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05198284 about?
NCT05198284 is a clinical study titled "Prospective Decision Impact Clinical Utility Trial of KidneyIntelX". The clinical utility trial is designed to evaluate how the results of KidneyIntelX test / platform impacts on the clinical management of type 2 diabetes patients identified as increased risk for rapid kidney function decline within 5-years.
What is the current status of trial NCT05198284?
This trial is currently active not recruiting. The enrollment target is 2,000 participants. The study started on 2021-11-01. Estimated completion is 2026-11-01.
What conditions does trial NCT05198284 study?
This clinical trial studies the following conditions: Chronic Kidney Diseases, Diabetic Kidney Disease, Chronic Kidney Disease Stage 3, Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 1. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05198284?
The interventions under investigation include: KidneyIntelX (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05198284?
This trial is sponsored by Renalytix AI, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05198284 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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