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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 17, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion date: Jul 2025 to Jul 2026
    • Study completion date: Oct 2025 to Oct 2026
    v7
  2. Notable Primary completion date: Jul 2024 to Jul 2025
    • Study completion date: Oct 2024 to Oct 2025
    v6
  3. Notable Primary completion date: Jul 2020 to Jul 2024
    • Study completion date: Oct 2020 to Oct 2024
    v5
  4. Minor Re-verified, no change to tracked fieldsv4
  5. Minor Start date changed from estimate of Jun 2019 to Sep 18, 2019
    • Study description expanded, about 143 words
    v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 15
    • Start date: May 2019 to Jun 2019
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT03893045
Lead Sponsor AMAG Pharmaceuticals, Inc.
Conditions
(from sponsor)
Iron Deficiency Anemia
Related terms Anemia, Anemia, Iron-Deficiency
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov