The purpose of this study is to look at subject incidence of adverse events.
To determine whether Epoetin alfa manufactured by a roller bottle technology (Epoetin alfa RB) and Epoetin alfa manufactured by a deep tank process (Epoetin alfa DT) have a comparable safety profile when administered to patients with CKD not on dialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
850
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 11.0 - 13.0 g/dL
Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 11.0 - 13.0 g/dL
Subject incidence of adverse events
Time frame: Entire Study
Epoetin alfa antibodies
Time frame: Entire Study
Changes from baseline laboratory and vital signs
Time frame: Entire Study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.