A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment

Inclusion Criteria:

1. Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities

2. Hemodialysis patients with chronic renal failure and renal anemia currently on stable Epogen (Amgen) treatment for at least 4 weeks prior to randomization, for whom the following apply (during this period):

   • Epogen (Amgen) dose has been administered IV or SC, 1-3 times per week
   • Hemoglobin levels were controlled within the range 9 to 11 g/dL, with not more than a ± 1.0 g/dL change from the mean over this period
3. Patients on stable, adequate dialysis for at least 12 weeks prior to randomization
4. Patients with adequate iron stores, defined as plasma ferritin >100 mcg/L and TSAT >20%, prior to randomization
5. Male or female patients aged 18 to 75 years (both inclusive)
6. If female, subject must be postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing birth control:

Exclusion Criteria:

1. Maintenance epoetin dosage >600 IU/kg per week (1-3 times per week)
2. Treatment with long-acting epoetin analogues such as Aranesp® within 12 weeks prior to randomization
3. Decompensated congestive heart failure (New York Heart Association [NYHA] class IV) within 3 months prior to randomization
4. Cerebrovascular accident within 3 months prior to randomization
5. Myocardial infarction within 3 months prior to randomization
6. Coronary angioplasty or bypass surgery within 3 months prior to randomization
7. Uncontrolled hypertension (defined as post-dialysis blood pressure >170/110 mmHg for patients within 0.5 kg of dry weight) within 4 weeks prior to randomization
8. Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective whether currently treated or not)
9. A patient with any active, uncontrolled systemic, inflammatory or malignant disease that in the Investigator's opinion may be significant to exclude participation in the study, including but not limited to microbial, viral, or fungal infection or mental disease (including demyelinating diseases such as multiple sclerosis)
10. Donated or lost >475 mL (i.e., 1 pint) blood volume (including plasmapheresis) or had a transfusion of any blood product within 3 months prior to randomization