The purpose of this study is to evaluate whether the efficacy of Epoetin alfa DT is equivalent to that of Epoetin alfa RB for the treatment of anemia in patients with CKD receiving hemodialysis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
420
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
Ratio of weekly dose at the evaluation period to the weekly dose at baseline
Time frame: Entire Study
Change in Heloglobin level between the screening period and the evaluation period
Time frame: Entire Study
Change from baseline Hb at each measurement timepoint
Time frame: Entire Study
Maintaining Hemoglobin within range at each measurement timepoint
Time frame: Entire Study
Average Epoetin alfa dose over evaluation period
Time frame: evaluation period (weeks 21 - 28)
Change from baseline dose at each measurement timepoint
Time frame: entire study
Epoetin alfa seroreactivity
Time frame: entire study
Subject incidence, nature and severity of adverse events
Time frame: entire study
Hemoglobin variability
Time frame: entire study
changes from baseline laboraotry and vital sign parameters
Time frame: entire study
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