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NCT01114139 · ClinicalTrials.gov registry record · Phase 3

A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia

A Phase 3 study, sponsored by AMAG Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
812
Enrollment target

NCT01114139: Completed Phase 3 study, sponsored by AMAG Pharmaceuticals.

NCT01114139 is a Phase 3 study that has completed, run by AMAG Pharmaceuticals. The registered enrollment target is 812 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01114139, a Phase 3 study, has completed, sponsored by AMAG Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
812 participants
Enrollment target

Study Summary

To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).

Primary Outcome

Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for an

Interventions

  • DRUG Ferumoxytol
  • OTHER Placebo

Trial Details

FieldValue
Enrollment Target 812 participants
Start Date 2010-06-19
Est. Completion 2012-10-22
Phase Phase 3
AMAG Pharmaceuticals

23 total trials

What the finished NCT01114139 record still lists

NCT01114139 is an interventional study that assigns participants to a tested intervention. The registered 812 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Ferumoxytol is the first listed.

NCT01114139 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01114139 about?

NCT01114139 is a clinical study titled "A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia". To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).

What is the current status of trial NCT01114139?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 812 participants. The study started on 2010-06-19. Estimated completion is 2012-10-22.

What interventions are being tested in trial NCT01114139?

The interventions under investigation include: Ferumoxytol (DRUG), Placebo (OTHER).

Who is sponsoring clinical trial NCT01114139?

This trial is sponsored by AMAG Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01114139's enrollment target sits among peer trials

812 408th of 2000 higher than 1,593 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT01114139, the US trial registry maintained by the National Library of Medicine. NCT01114139 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.