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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
320
Variable dose
Variable dose
North America Research Institute
Azusa, California, United States
National Institute of Clinical Research
Bakersfield, California, United States
Long Beach Dialysis Center
Long Beach, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
Long Beach Dialysis Center
Modesto, California, United States
Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period
Time frame: Week 30 up to Week 34
Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period
Time frame: Week 30 up to Week 34
Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period
Time frame: Week 19 up to Week 34
Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period
Time frame: Week 19 up to Week 34
Total Dose of Study Medication Administered: Maintenance Period
In this outcome measure mean of total dose of study medication administered in maintenance period was reported.
Time frame: Week 19 up to Week 34
Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period
Percentage of participants who had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.
Time frame: Week 26, 34
Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period
Time frame: Week 19 up to Week 34
Percentage of Participants Who Required Temporary Dose Changes: Maintenance Period
Time frame: Week 19 up to Week 34
Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1.0 Gram Per Deciliter (g/dL): Maintenance Period
Time frame: Week 19 up to Week 34
Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range: Maintenance Period
Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.
Time frame: Week 26, 34
Percentage of Participants Who Qualified as Optimally Titrated and Stable: Titration Period
Time frame: Week 1 up to Week 18
Percentage of Participants Who Received Blood Transfusions: Maintenance Period
Time frame: Week 19 up to Week 34
Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level: Maintenance Period
In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: \>11.0 g/dL, from 9.0 to 11.0 g/dL and \<9.0 g/dL
Time frame: Week 19 up to Week 34
Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level: Maintenance Period
Time frame: Week 19 up to Week 34
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