• The primary measure of the effectiveness in the study is the change in hemoglobin value from baseline to the average of the last 8 weeks of treatment through Week 22 [ Time Frame: The primary efficacy endpoint of the study is the change in hemoglobin from baseline to Week 22. ] [ Designated as safety issue: No ]
  

• The secondary efficacy endpoint of the study is the proportion of patients with an increase in hemoglobin value from baseline greater than or equal to 1 g/dL by Week 9 [ Time Frame: The secondary efficacy endpoint of the study is the proportion of subjects with an increase in hemoglobin value from baseline by Week 9. ] [ Designated as safety issue: No ]
  

A consequence of chronic kidney disease is anemia due to decreased production of erythropoietin. Anemia is associated with decreased oxygen delivery and utilization, and can result in fatigue, lethargy, decreased cognition and mental acuity, and cardiac complications.This study was designed to compare 2 dosing regimens, once weekly and once every-2-weeks with the 3 times weekly dosing regimen. Men and women who are diagnosed with anemia associated with chronic kidney disease will participate in this study. Approximately 375 patients will be included. This is a randomized (patients are assigned to different treatments based on chance), open-label, multicenter study of epoetin alfa in patients who are not on dialysis. The study is 48 to 50 weeks in duration. All eligible patients will be treated with epoetin alfa according to one of the following 3 regimens: 3 times weekly injection (Group 1), or once weekly injection (Group 2), or once every-2-weeks injection (Group 3) for 22 weeks. Thereafter, patients in Group 1 will be treated with epoetin alfa once weekly for an additional 22 weeks. Patients in Groups 2 and 3 will continue their current treatment for an additional 22 weeks. The maximum volume per injection will not be more than 1 mL. The total duration of the open-label treatment phase in this study is 44 weeks, which includes initiation treatment (with the goal of increasing the hemoglobin level to 11.0 to 12.0 g/dL inclusive), maintenance treatment (with the goal of keeping the hemoglobin level within this range), and a safety period (to assess longer exposure to epoetin alfa treatment and any period of hemoglobin instability during the transition from 3 -times-weekly to once-weekly dosing, compared with ongoing once-weekly and every 2 week dosing). The primary hypothesis is that the average change in hemoglobin level from baseline to the average of the last 8 weeks of treatment through Week 22 in the once-weekly and every 2-weeks groups is not lower than the change in hemoglobin level by more than 1 g/dL in the group that received epoetin alfa 3 times weekly. Adverse events will be monitored throughout the study. Clinical laboratory examinations, vital signs, and physical examinations will be conducted routinely to ensure patient safety.

Approximately 1 mL of epoetin alfa will be injected under the skin either once a week (10,000 IU), once every 2 weeks (20,000 IU), or 3 times a week (50 IU/kg) for up to 44 weeks of treatment.