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NCT01628107 · ClinicalTrials.gov registry record · Phase 3
A Phase 3, Long-Term Safety Study of Intravenous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 406
- Enrollment target
NCT01628107: Completed Phase 3 study, sponsored by Pfizer.
NCT01628107 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 406 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01628107, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 406 participants
- Enrollment target
Study Summary
The purpose of the study is to determine the long-term safety in treatment-emergent adverse events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal failure and on hemodialysis.
Primary Outcome
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state.
Interventions
- BIOLOGICAL Epoetin Hospira
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 406 participants |
| Start Date | 2012-07-16 |
| Est. Completion | 2015-01-02 |
| Phase | Phase 3 |
What the finished NCT01628107 record still lists
NCT01628107 is an interventional study that assigns participants to a tested intervention. The registered 406 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which Epoetin Hospira is the first listed.
NCT01628107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01628107 about?
NCT01628107 is a clinical study titled "A Phase 3, Long-Term Safety Study of Intravenous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin". The purpose of the study is to determine the long-term safety in treatment-emergent adverse events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal failure and on hemodialysis.
What is the current status of trial NCT01628107?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 406 participants. The study started on 2012-07-16. Estimated completion is 2015-01-02.
What interventions are being tested in trial NCT01628107?
The interventions under investigation include: Epoetin Hospira (BIOLOGICAL).
Who is sponsoring clinical trial NCT01628107?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01628107's enrollment target sits among peer trials
406 913th of 2000 higher than 1,087 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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