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NCT04864847 · ClinicalTrials.gov registry record
Clinical Validation of the RENISCHEM L-FABP POC Assay
A clinical trial of Acute Kidney Injury and Contrast Induced Nephropathy, sponsored by Hikari Dx.
- Active
- Registry status
- 450
- Enrollment target
- 6
- Study locations
NCT04864847: Active study of Acute Kidney Injury and Contrast Induced Nephropathy, sponsored by Hikari Dx.
NCT04864847 is a study of Acute Kidney Injury and Contrast Induced Nephropathy that is active but no longer recruiting, run by Hikari Dx. The registered enrollment target is 450 participants, below the 2,325-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (81% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04864847, a study of Acute Kidney Injury and Contrast Induced Nephropathy, is active but no longer recruiting, sponsored by Hikari Dx.
- ACTIVE NOT RECRUITING
- Registry status
- 450 participants
- Enrollment target
- 6
- Study locations
Study Summary
This study will involve measurement of levels of a novel urinary biomarker of renal ischemia, L-FABP. The purpose of the study is to perform a clinical validation of the ability of L-FABP measurements in urine using the RENISCHEM L-FABP POC Test to predict the development of AKI within 2 days following cardiac and vascular catheterization procedures involving exposure to radiocontrast media.
Primary Outcome
AKI defined as stage 1, 2, or 3 using the KDIGO criteria
Conditions Studied
Interventions
- DIAGNOSTIC_TEST RENISCHEM L-FABP POC Test
Study Locations (6)
Florida
- Clearwater Cardiovascular Consultants - Clearwater
- University of Florida at Jacksonville - Jacksonville
Arizona
- Chandler Regional Medical Center - Chandler
California
- John Muir Health - Concord
Maryland
- Sinai Hospital of Baltimore - Baltimore
Oklahoma
- University of Oklahoma - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2026-02 |
What the registry record for NCT04864847 still lists
NCT04864847 is an observational study that tracks outcomes without assigning an intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 2,325-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Acute Kidney Injury appearing as the primary indexed condition, and to 1 intervention - of which RENISCHEM L-FABP POC Test is the first listed.
NCT04864847 lists 6 locations in 5 states (Florida, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT04864847 about?
NCT04864847 is a clinical study titled "Clinical Validation of the RENISCHEM L-FABP POC Assay". This study will involve measurement of levels of a novel urinary biomarker of renal ischemia, L-FABP. The purpose of the study is to perform a clinical validation of the ability of L-FABP measurements in urine using the RENISCHEM L-FABP POC Test to predict the development of AKI within 2 days follow...
What is the current status of trial NCT04864847?
This trial is currently active not recruiting. The enrollment target is 450 participants. The study started on 2021-10-01. Estimated completion is 2026-02.
What conditions does trial NCT04864847 study?
This clinical trial studies the following conditions: Acute Kidney Injury, Contrast Induced Nephropathy.
What interventions are being tested in trial NCT04864847?
The interventions under investigation include: RENISCHEM L-FABP POC Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04864847?
This trial is sponsored by Hikari Dx, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04864847 being conducted?
This trial has 6 study locations across Arizona, California, Florida, Maryland, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04864847's enrollment target sits among peer trials
450 19th of 74 higher than 55 of 74 other Acute Kidney Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Kidney Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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