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A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)

StatusRecruiting
PhasePhase 3
Started
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Record status
This record was last updated April 17, 2026 (before its estimated August 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary and study completion dates: Aug 31, 2024 to Aug 31, 2026v10
  2. Primary and study completion dates: Aug 31, 2023 to Aug 31, 2024v9
  3. Primary completion date: Mar 31, 2023 to Aug 31, 2023v8
  4. Primary completion date: Aug 31, 2021 to Mar 31, 2023
    • Study completion date: Jan 31, 2022 to Aug 31, 2023
    • Site details revised at 5 of 21 sites
    v7
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary endpoint revised
    • Study description expanded, about 174 words
    v5
  2. Study sites: 1 to 21v4
  3. Re-verified, no change to tracked fieldsv3
  4. Start date changed from estimate of Aug 15, 2018 to Aug 13, 2018v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Primary Objectives: To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA Secondary Objective: To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.
Trial Details
NCT Number NCT03619850
Lead Sponsor AMAG Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Chronic Kidney Disease; Iron Deficiency Anemia
Related terms Anemia, Iron-Deficiency, Renal Insufficiency, Chronic
Enrollment 129 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov