Trials / Completed
CompletedNCT01473407
A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
A Therapeutic-equivalence Study Comparing The Efficacy And Safety Of Intravenous Epoetin Hospira And Epoetin Alfa (Amgen) In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 612 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira compared to IV Epogen (Amgen), based on maintenance of Hb levels and study drug dose requirements in patients treated for anemia associated with chronic renal failure and on hemodialysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Epoetin Hospira | Variable dose |
| BIOLOGICAL | Epogen (Amgen) | Variable dose |
Timeline
- Start date
- 2012-01-31
- Primary completion
- 2014-02-11
- Completion
- 2014-02-11
- First posted
- 2011-11-17
- Last updated
- 2018-09-10
- Results posted
- 2018-07-13
Locations
85 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT01473407. Inclusion in this directory is not an endorsement.