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
Condition: Chronic Renal Failure Requiring Hemodialysis
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Intervention: Epoetin Hospira
Intervention description: Intravenous (IV) injection
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 406.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic renal failure; hemodialysis

Summary:

      The purpose of the study is to determine the long-term safety in treatment-emergent adverse
      events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of
      target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal
      failure and on hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient is able to provide written Informed Consent after the risks and benefits of
             the 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 Epoetin
             Hospira 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, or
             hysterectomy), or practicing at least 1 of the following methods of birth control:

               -  Hormonal contraceptives (oral, parenteral, or transdermal) for at least 3 months
                  prior to enrollment

               -  Intrauterine device

               -  Double-barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ring
                  with spermicidal jellies or cream)

             If hormonal contraceptives are used, the specific contraceptive must have been used
             for at least 3 months prior to enrollment. If the patient is currently using a
             hormonal contraceptive, she should also use a barrier method during this study and for
             at 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 throughout
             the 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 opinion
             of the Investigator, was probably or definitely related to epoetin use and precluded
             safe 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) 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)

          3. A patient with any active, uncontrolled systemic, inflammatory, or malignant disease
             that developed during the core study and 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.

          4. Any newly developed 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 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 as
             determined by the Investigator.

          7. Current participation or participation in a drug or other investigational research
             study within 30 days prior to enrollment (except the core study or any observational
             studies with prior written approval from Hospira).

          8. 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.

          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 abnormal
             laboratory results that may impact patient safety.