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NCT03523117 · ClinicalTrials.gov registry record · Phase 3
Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
A Phase 3 study of Iron Deficiency Anemia, sponsored by American Regent.
- Completed
- Registry status
- Phase 3
- Development phase
- 79
- Enrollment target
- 16
- Study locations
NCT03523117: Completed Phase 3 study of Iron Deficiency Anemia, sponsored by American Regent.
NCT03523117 is a Phase 3 study of Iron Deficiency Anemia that has completed, run by American Regent. The registered enrollment target is 79 participants, below the 190-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (58% lower). The trial reports 16 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03523117, a Phase 3 study of Iron Deficiency Anemia, has completed, sponsored by American Regent.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 79 participants
- Enrollment target
- 16
- Study locations
Study Summary
The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.
Primary Outcome
Change in hemoglobin g/dL from baseline to day 35 will be analyzed using parametric analysis of covariance (ANCOVA). The model will include terms for the randomization strata (hemoglobin and age categories), baseline hemoglobin, as well as treatment group. Baseline hemoglobin will be defined as the last hemoglobin obtained before randomization.
Conditions Studied
Interventions
- DRUG Ferrous Sulfate
- DRUG Ferric carboxymaltose
Study Locations (16)
Florida
- International Research Partners, Inc. - Doral
- ProHealth Research Center - Doral
- Garden Medical Research, Inc. - Miami
- Miami Clinical Research - Miami
- South Florida Research Phase I-IV - Miami Springs
Texas
- Cook Children's Medical Center - Fort Worth
- Baylor College of Medicine/Texas Children Hospital - Houston
- Tekton Research - San Antonio
Ohio
- Cincinnati Children's Hospital and Medical Center - Cincinnati
- Cincinnati Children's Hospital Medical Center - Cincinnati
Arkansas
- Arkansas Children's Hospital - Little Rock
Indiana
- Riley Hospital for Children,Room 4340 - Indianapolis
Michigan
- Caro Health Plaza - Caro
Missouri
- Galen Research - Chesterfield
New York
- Tiga Pediatrics, PC - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2021-01-29 |
| Phase | Phase 3 |
What the finished NCT03523117 record still lists
NCT03523117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 190-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Iron Deficiency Anemia appearing as the primary indexed condition, and to 2 interventions - of which Ferrous Sulfate is the first listed.
NCT03523117 lists 16 locations in 9 states (Florida, Texas, Ohio).
Frequently Asked Questions
What is clinical trial NCT03523117 about?
NCT03523117 is a clinical study titled "Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA". The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.
What is the current status of trial NCT03523117?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 79 participants. The study started on 2019-01-31. Estimated completion is 2021-01-29.
What conditions does trial NCT03523117 study?
This clinical trial studies the following conditions: Iron Deficiency Anemia.
What interventions are being tested in trial NCT03523117?
The interventions under investigation include: Ferrous Sulfate (DRUG), Ferric carboxymaltose (DRUG).
Who is sponsoring clinical trial NCT03523117?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03523117 being conducted?
This trial has 16 study locations across Arkansas, Florida, Indiana, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Iron Deficiency Anemia
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 NCT03523117's enrollment target sits among peer trials
79 13th of 24 higher than 12 of 24 other Iron Deficiency Anemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Iron Deficiency Anemia 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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