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NCT03893045 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
A Phase 3 study of Iron Deficiency Anemia, sponsored by AMAG Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
- 15
- Study locations
NCT03893045 is a Phase 3 study of Iron Deficiency Anemia that is actively recruiting participants, run by AMAG Pharmaceuticals. The registered enrollment target is 75 participants, below the 191-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (61% lower). The trial reports 15 study locations across 5 states.
The verdict
NCT03893045, a Phase 3 study of Iron Deficiency Anemia, is actively recruiting participants, sponsored by AMAG Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
- 15
- Study locations
Study Summary
This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to \<18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. This study allows for enrollment of subjects with IDA regardless of etiology, except for CKD subjects (pediatric CKD subjects are being studied in a separate ferumoxytol protocol).
Conditions Studied
Interventions
- DRUG Iron sucrose
- DRUG ferumoxytol
Study Locations (15)
Other
- JSC Saules seimos medicinos centras - Kaunas
- Klaipeda Children's Hospital - Klaipėda
- Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos - Vilnius
- Osrodek Badan Klinicznych In Vivo sp. z o.o. - Bydgoszcz
- Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek - Dębica
- Pro Familia Altera Sp. z o.o. - Katowice
- Korczowski Bartosz, Gabinet Lekarski - Rzeszów
- Centrum Zdrowia MDM - Warsaw
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu - Wroclaw
Florida
- University of Florida - Gainesville
- Optimus U Corporation - Miami
- Biomedical Research LLC - Miami
Arkansas
- Arkansas Children's Hospital - Little Rock
Georgia
- Gwinnett Research Institute - Buford
Texas
- Sun Research Institute - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2019-09-18 |
| Est. Completion | 2025-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03893045
The ClinicalTrials.gov registry entry for NCT03893045 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 191-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (61% lower). The listed sponsor is AMAG Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Iron Deficiency Anemia appearing as the primary indexed condition, and to 2 interventions - of which Iron sucrose is the first listed.
NCT03893045 reports 15 study locations spanning 5 distinct geographic areas - top geographies include Other, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT03893045 about?
NCT03893045 is a clinical study titled "A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects". This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to \<18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. This study allows for enrollment of subjects with IDA regardless of etiology, except for CKD subjec...
What is the current status of trial NCT03893045?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2019-09-18. Estimated completion is 2025-10.
What conditions does trial NCT03893045 study?
This clinical trial studies the following conditions: Iron Deficiency Anemia.
What interventions are being tested in trial NCT03893045?
The interventions under investigation include: Iron sucrose (DRUG), ferumoxytol (DRUG).
Who is sponsoring clinical trial NCT03893045?
This trial is sponsored by AMAG Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03893045 being conducted?
This trial has 15 study locations across Arkansas, Florida, Georgia, Texas. 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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