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NCT02399449 · ClinicalTrials.gov registry record · Phase 4
IV Iron Safety: Evaluation of Iron Species in Healthy Subjects
A Phase 4 study of Anemia, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT02399449 is a Phase 4 study of Anemia that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 110 participants, below the 426-participant average among 72 other Anemia trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02399449, a Phase 4 study of Anemia, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study Summary
An approved treatment for anemia or low blood count due to chronic kidney disease is IV (intravenous, given into the vein) injection of an iron treatment. IV iron increases iron in the blood. Many IV iron therapies are now available in both brand name and generic forms. One common IV iron product is sodium ferric gluconate (SFG) sold as brand name Ferrlecit. Recently, a generic version of Ferrlecit was approved but was felt to be possibly more toxic than the brand product. The purpose of this research project is to see if the brand and generic IV iron products produce the same amount of iron in the blood in healthy volunteers, including an iron form that more toxic than other iron forms.
Conditions Studied
Interventions
- DRUG Brand sodium ferric gluconate
- DRUG Generic sodium ferric gluconate
Study Locations (1)
Maryland
- University of Maryland - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2017-09-15 |
| Est. Completion | 2019-04-25 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02399449
The ClinicalTrials.gov registry entry for NCT02399449 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 426-participant average among 72 other Anemia trials with a reported enrollment target (74% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Anemia appearing as the primary indexed condition, and to 2 interventions - of which Brand sodium ferric gluconate is the first listed.
NCT02399449 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02399449 about?
NCT02399449 is a clinical study titled "IV Iron Safety: Evaluation of Iron Species in Healthy Subjects". An approved treatment for anemia or low blood count due to chronic kidney disease is IV (intravenous, given into the vein) injection of an iron treatment. IV iron increases iron in the blood. Many IV iron therapies are now available in both brand name and generic forms. One common IV iron product is...
What is the current status of trial NCT02399449?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2017-09-15. Estimated completion is 2019-04-25.
What conditions does trial NCT02399449 study?
This clinical trial studies the following conditions: Anemia.
What interventions are being tested in trial NCT02399449?
The interventions under investigation include: Brand sodium ferric gluconate (DRUG), Generic sodium ferric gluconate (DRUG).
Who is sponsoring clinical trial NCT02399449?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02399449 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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