A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin

Exclusion Criteria

• •1. Maintenance epoetin dosage \>600 U/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. Any of the following within 3 months prior to randomization:
• •* Myocardial infarction
• •* Stroke (cerebrovascular accident)/cerebrovascular insult (minor stroke) or transient ischemic attack/intracerebral bleeding/cerebral infarction
• •* Severe/unstable angina
• •* Coronary angioplasty, bypass surgery, or peripheral artery bypass graft
• •* Decompensated congestive heart failure (New York Heart Association \[NYHA\] class IV)
• •* Pulmonary embolism
• •* Deep vein thrombosis or other thromboembolic event
• •* Received live or attenuated vaccination (except flu vaccination)
• •4. Uncontrolled hypertension within the 4 weeks prior to randomization defined as more than 10% of post-dialysis blood pressures \>170 mmHg systolic and/or \>110 mmHg diastolic, based on blood pressure readings obtained when the patient's post-dialysis body weight was not more than 0.5 kg above their listed dry weight
• •5. Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective of whether currently treated or not)
• •6. 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 demyelinating diseases such as multiple sclerosis, microbial, viral or fungal infection or mental disease
• •7. Contraindication for the test drug or have been previously treated with Epoetin Hospira
• •8. Relative or absolute iron deficiency prior to randomization into the Maintenance Period
• •9. Platelet count below 100 x 10\^9/L
• •10. Clinically relevant increase of CRP (\>10 mg/dL) for at least 2 weeks
• •11. Significant drug sensitivity or a significant allergic reaction to any drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients, including albumin) or any other related drugs that in the judgment of the Investigator is exclusionary for the study participation
• •12. History of any of the following:
• •* Detectable anti-rhEPO antibodies
• •* Clinically relevant malnutrition
• •* Confirmed aluminum intoxication
• •* Myelodysplastic syndrome
• •* Known bone marrow fibrosis (osteitis fibrosa cystica)
• •* Known seizure disorder
• •* Liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites)
• •13. A female patient who is pregnant, lactating or planning a pregnancy during the study
• •14. History of drug abuse or alcohol abuse within 2 years prior to randomization as determined by the Investigator
• •15. Current participation or participation in a drug or other investigational research study within 30 days prior to randomization
• •16. May not be able to comply with the requirements of this clinical study, communicate effectively with study personnel, or is considered by the Investigator, for any reason, to be an unsuitable candidate for the study
• •17. 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
• •18. A patient who in the Investigator's opinion, has any clinically significant abnormal laboratory evaluations, including liver function taken at Screening Visit
• •19. Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg)