A Study Comparing the Effects of Epoetin Hospira and Epogen/Epoetin Alfa (Amgen) When Administered IV in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment
NCT01170078 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 107
Last updated 2017-03-20
Summary
This study assessed the comparability of the pharmacokinetics (PK) of epoetin following intravenous administration of Hospira Epoetin and Epogen/Epoetin Alfa (Amgen) in patients with chronic renal failure receiving hemodialysis treatment.
Conditions
- Chronic Renal Failure
Interventions
- DRUG
-
Epoetin Hospira
IV dose 3 times a week.
- DRUG
-
Epogen
IV dose 3 times a week
Sponsors & Collaborators
-
Hospira, now a wholly owned subsidiary of Pfizer
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-07-31
- Primary Completion
- 2011-01-31
- Completion
- 2011-01-31
Countries
- United States
Study Locations
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