A Phase 3, Long-Term Safety Study of Intravenous Epoetin Hospira 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 the risks and benefits ofthe study have been explained prior to any study-related activities.

2. Patient previously completed the core study Treatment Period up to and including Week 24 study assessments per protocol and is willing to continue open-label EpoetinHospira for up to 48 weeks.

3. If female, patient must be postmenopausal for at least 1 year prior to enrollment,surgically sterile (bilateral tubal ligation, bilateral oophorectomy, orhysterectomy), or practicing at least 1 of the following methods of birth control:

• Hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 monthsprior to enrollment

• Intrauterine device

• 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 usedfor at least 3 months prior to enrollment. If the patient is currently using ahormonal contraceptive, she should also use a barrier method during this study and forat least 30 days following the administration of the patient's last open-label dose.

4. Adequate methods of contraception to prevent pregnancy are to be maintained throughoutthe course of the study in both male and female study subjects.

Exclusion Criteria:

1. Patient had a serious or severe adverse event in the core study that, in the opinionof the Investigator, was probably or definitely related to epoetin use and precludedsafe use of epoetin.

2. Any of the following that developed during the core study and prior to enrollment:

• 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)

3. A patient with any active, uncontrolled systemic, inflammatory, or malignant diseasethat developed during the core study and in the Investigator's opinion may besignificant to exclude participation in the study, including but not limited todemyelinating diseases such as multiple sclerosis, microbial, viral, or fungalinfection or mental disease.

4. Any newly developed significant drug sensitivity or a significant allergic reaction toany drug, as well as known hypersensitivity or idiosyncratic reaction to epoetin (orits excipients, including albumin) or any other related drugs that in the judgment ofthe Investigator is exclusionary for study participation.

5. A female patient who is pregnant, lactating, or planning a pregnancy during the study.

6. History of drug abuse or alcohol abuse during the core study prior to enrollment asdetermined by the Investigator.

7. Current participation or participation in a drug or other investigational researchstudy within 30 days prior to enrollment (except the core study or any observationalstudies with prior written approval from Hospira).

8. 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.

9. Evidence of human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg).

10. A patient who, in the Investigator's opinion, has any clinically significant abnormallaboratory results that may impact patient safety.