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
(AiME - 13 Trial)
Recruiting in Palo Alto (17 mi)
+72 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Pfizer
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
Inclusion Criteria
Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities
A change in Epogen dosing of no more than 10% from the mean
Mean hemoglobin between 9.0 and 11.0 g/dL
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Treatment Details
Interventions
- Epoetin Hospira (Erythropoiesis-Stimulating Agent)
- Epogen Amgen (Erythropoiesis-Stimulating Agent)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Epoetin HospiraExperimental Treatment1 Intervention
Epoetin Hospira
Group II: Epogen (Amgen)Active Control1 Intervention
Epogen (Amgen)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Institute of Clinical ResearchBakersfield, CA
Long Beach Dialysis CenterLong Beach, CA
Innovative Dialysis Center of Northridge, LLCNorthridge, CA
Valley Renal Medical GroupNorthridge, CA
More Trial Locations
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Who Is Running the Clinical Trial?
PfizerLead Sponsor
Hospira, now a wholly owned subsidiary of PfizerIndustry Sponsor