Trials / Completed
CompletedNCT01473420
A Phase 3 Study Comparing the Effects of Subcutaneous 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 Subcutaneous 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
- 320 (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 subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (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
- 2012-01-17
- Primary completion
- 2014-02-28
- Completion
- 2014-02-28
- First posted
- 2011-11-17
- Last updated
- 2018-08-09
- Results posted
- 2018-06-20
Locations
73 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01473420. Inclusion in this directory is not an endorsement.