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RECRUITING Phase 3

A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects

NCT03893045 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 75 participants
Start Date 2019-09-18
Est. Completion 2025-10
Phase Phase 3

Sponsor

AMAG Pharmaceuticals

3 total trials

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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. It is categorized as Phase 3, 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 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AMAG Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. 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: NCT03893045 reports 15 study locations spanning 5 distinct geographic areas — top geographies include Other, Florida, Arkansas. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03893045?

The interventions under investigation include: Iron sucrose (DRUG), ferumoxytol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03893045?

This trial is sponsored by AMAG Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial