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NCT01227616 · ClinicalTrials.gov registry record · Phase 4
Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis
A Phase 4 study, sponsored by AMAG Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 296
- Enrollment target
NCT01227616: Completed Phase 4 study, sponsored by AMAG Pharmaceuticals.
NCT01227616 is a Phase 4 study that has completed, run by AMAG Pharmaceuticals. The registered enrollment target is 296 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01227616, a Phase 4 study, has completed, sponsored by AMAG Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 296 participants
- Enrollment target
Study Summary
The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.
Primary Outcome
Changes in the mean hemoglobin between Baseline and Week 5 for ferumoxytol and iron sucrose in each treatment period.
Interventions
- DRUG Ferumoxytol
- DRUG Iron Sucrose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2013-08 |
| Est. Completion | 2017-02 |
| Phase | Phase 4 |
What the finished NCT01227616 record still lists
NCT01227616 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which Ferumoxytol is the first listed.
NCT01227616 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01227616 about?
NCT01227616 is a clinical study titled "Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis". The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.
What is the current status of trial NCT01227616?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 296 participants. The study started on 2013-08. Estimated completion is 2017-02.
What interventions are being tested in trial NCT01227616?
The interventions under investigation include: Ferumoxytol (DRUG), Iron Sucrose (DRUG).
Who is sponsoring clinical trial NCT01227616?
This trial is sponsored by AMAG Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01227616's enrollment target sits among peer trials
296 294th of 2000 higher than 1,707 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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