The purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira compared to IV Epogen (Amgen), based on maintenance of 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
612
Variable dose
Variable dose
Montgomery Kidney Specialists
Montgomery, Alabama, United States
Southwest Clinical Research Institute, LLC
Tempe, Arizona, United States
Lakhi M. Sakhrani, MD A Medical Coporation
Alhambra, California, United States
North America Research Institute
Azusa, California, United States
DaVita Dialysis Center-Bakersfield Dialysis Center
Bakersfield, California, United States
Mean Weekly Hemoglobin Level From Week 21 to Week 24
Time frame: Week 21 up to Week 24
Mean Weekly Dosage of Study Medication From Week 21 to Week 24
Time frame: Week 21 up to Week 24
Mean Weekly Hemoglobin Level Through 24 Weeks
Time frame: Week 1 up to Week 24
Mean Weekly Dosage of Study Medication Through 24 Weeks
Time frame: Week 1 up to Week 24
Total Dose of Study Medication Administered
Time frame: Week 1 up to Week 24
Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range
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 12, 24
Percentage of Participants Who Required Permanent Dose Changes of Study Medication
Time frame: Week 1 up to Week 24
Percentage of Participants Who Required Temporary Dose Changes of Study Medication
Time frame: Week 1 up to Week 24
Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL)
Time frame: Week 1 up to Week 24
Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range
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 12, 24
Percentage of Participants Who Received Blood Transfusions
Time frame: Week 1 up to Week 24
Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level
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 1 up to Week 24
Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level
Time frame: Week 1 up to Week 24
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Ong, Rubin, Shahmir A Medical Corp DBA: Solano Kidney Care
Fairfield, California, United States
A Medical Corporation
Glendale, California, United States
Renal Consultants Medical Group
Granada Hills, California, United States
La Puente Dialysis Center
La Puente, California, United States
Advanced Medical Research, LLC
Lakewood, California, United States
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