At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 320 enrolled
Drug / intervention
Epoetin Hospira +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Epoetin Hospira and Epogen Amgen for Chronic Renal Failure and Chronic Kidney Disease. Completed, enrolled 320 participants across 73 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Renal Failure, Chronic Kidney Disease
CountriesUnited States
CollaboratorsHospira, now a wholly owned subsidiary of Pfizer
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartJan 2012
Primary CompletionFeb 2014
TodayJul 2026
First PostedNov 17, 2011
Enrollment StartJan 17, 2012
Primary CompletionFeb 28, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.6 years ago
Interventions
Epoetin Hospirabiological
Variable dose
Epogen Amgenbiological
Variable dose