A Phase 3 Study Comparing the Effects of Intravenous 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

Inclusion Criteria:

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

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

• Epogen (Amgen) dose has been administered intravenously 1 to 3 times per weekwith no more than a 10% dose change from the mean for at least 4 weeks prior torandomization

• Stable hemoglobin, defined as meeting all of the following:

• Mean hemoglobin during the 4 weeks prior to randomization between 9.0 and 11.0 g/dL

• No more than one hemoglobin outside of range from 9.0-11.0 g/dL during the 4weeks prior to randomization

• No hemoglobin result more than ±1 g/dL from the mean hemoglobin level duringthe 4 week period prior to randomization

3. Patients on stable, adequate dialysis for at least 12 weeks prior to randomization,defined as no clinically relevant changes of dialysis regimen and/or dialyzer

4. Patients with adequate iron stores, defined as ferritin >100 μg/L and TSAT >20%, priorto randomization

5. Male or female patients aged 18 to 80 years (both inclusive)

6. If female, patient must be either postmenopausal for at least 1 year prior torandomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy,or hysterectomy), or practicing at least 1 of the following methods of birth control:

• hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 monthsprior to randomization

• intrauterine device (IUD)

• double-barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ringwith spermicidal jellies or cream) If hormonal contraceptives are used, the specific contraceptive must have been used for atleast 3 months prior to randomization. If the patient is currently using a hormonalcontraceptive, she should also use a barrier method during this study and for at least 30days following the administration of the patient's last dose

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 3 months priorto randomization

3. Any of the following within 3 months prior to randomization:

• Myocardial infarction

• Stroke (cerebrovascular accident)/cerebrovascular insult (minor stroke) ortransient 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] classIV)

• 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 morethan 10% of post-dialysis blood pressures >170 mmHg systolic and/or >110 mmHgdiastolic, based on blood pressure readings obtained when the patient's post-dialysisbody 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 (irrespectiveof whether currently treated or not)

6. A patient with any active, uncontrolled systemic, inflammatory or malignant disease (including demyelinating diseases such as multiple sclerosis) that in theInvestigator's opinion may be significant to exclude participation in the study,including but not limited to microbial, viral, or fungal infection or mental disease

7. Contraindication for the test drug or have been previously treated with EpoetinHospira

8. Relative or absolute iron deficiency prior to randomization

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 wellas known hypersensitivity or idiosyncratic reaction to epoetin (or its excipients,including albumin) or any other related drugs that in the judgment of the Investigatoris 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 asdetermined by the Investigator

15. Current participation or participation in a drug or other investigational researchstudy within 30 days prior to randomization

16. May not be able to comply with the requirements of this clinical study, communicateeffectively with study personnel, or is considered by the Investigator, for anyreason, to be an unsuitable candidate for the study

17. Donated or lost >475 mL (i.e., 1 pint) blood volume (including plasmapheresis) or hada transfusion of any blood product within 3 months prior to randomization

18. A patient who in the Investigator's opinion, has any clinically significant abnormallaboratory evaluations, including liver function taken at Screening Visit

19. Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surfaceantigen (HBsAg)