A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin

Study Overview
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Brief Summary
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To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal failure and on hemodialysis.

Official Title
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A Phase 3, Open-label, Multicenter, Long-term Safety Study Of Subcutaneous Epoetin Hospira In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment

Conditions
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Chronic Renal Failure Requiring Hemodialysis

Intervention / Treatment
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* Biological: Epoetin Hospira


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Patient previously completed the core study Maintenance Period up to and including Week 16 study assessments per protocol and is willing to continue open-label Epoetin Hospira for up to 48 weeks. 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. 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: 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. 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) 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. 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. A female patient who is pregnant, lactating, or planning a pregnancy during the study. History of drug abuse or alcohol abuse during the core study prior to enrollment as determined by the Investigator. 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). 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. Evidence of human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg). A patient who, in the Investigator's opinion, has any clinically significant abnormal laboratory results that may impact patient safety.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epoetin Hospira<br>Epoetin Hospira will be administered by SC bolus injection 1 to 3 times per week per each patient's dosing schedule. Other ESAs (except for long-acting) may be used as rescue therapy. | Biological: Epoetin Hospira<br>* Subcutaneous(SC) injection<br>* Other names: Erythropoetin Stimulation Agents;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Up through 7 days after first dose of study drug (Week 1) | 
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Week 1 up to Week 12 | 
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Week 13 up to Week 24 | 
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Week 25 up to Week 36 | 
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Week 37 up to Week 48 | 
| Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment emergent are events that emerged during the treatment period and were absent before treatment or that worsened relative to pretreatment state. | Week 1 up to Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Weekly Dosage of Epoetin Hospira: Over Week 1 to 48 |  | Week 1 up to Week 48 | 
| Mean Weekly Dosage of Epoetin Hospira for Interval of 12 Weeks |  | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 | 
| Mean Hemoglobin Levels: Over Week 1 to 48 |  | Week 1 up to Week 48 | 
| Mean Hemoglobin Levels for Interval of 12 Weeks |  | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 | 
| Mean Hematocrit Levels: Over Week 1 to 48 | Hematocrit is defined as the percentage of red blood cells in the blood. | Week 1 up to Week 48 | 
| Mean Hematocrit Levels for Interval of 12 Weeks | Hematocrit is defined as the percentage of red blood cells in the blood. | Week 1 up to Week 12; Week 13 up to Week 24; Week 25 up to Week 36; Week 37 up to Week 48 | 
| Percentage of Participants With Hemoglobin Level Outside Target Range | Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported. | Week 1 up to Week 48 | 
| Percentage of Participants Who Received Blood Transfusions |  | Week 1 up to Week 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic renal failure, Hemodialysis