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

Completed · Phase 3

Conditions studied: Chronic Renal Failure Requiring Hemodialysis

In brief

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.

Key facts

Study ID

NCT01628120

Run by

Pfizer

People needed

170

Starts

2012-05-31

Expected to finish

2015-02-13

Last updated by the study team

2019-03-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Azusa, California, United States
• Pegasus Dialysis — Bakersfield, California, United States
• National Institute of Clinical Research — Bakersfield, California, United States
• Study site — Bakersfield, California, United States
• Bellflower Dialysis Center — Bellflower, California, United States
• Study site — Granada Hills, California, United States
• Lakewood Dialysis Center — Lakewood, California, United States
• Westcoast Dialysis — Long Beach, California, United States
• Long Beach Dialysis — Long Beach, California, United States
• Novo Research — Long Beach, California, United States
• Study site — Long Beach, California, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• East LA Dialysis Center — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Modesto Kidney Center — Modesto, California, United States
• Novo Research, Inc. d/b/a Foundation Research — Modesto, California, United States
• Parkway Kidney Center — Modesto, California, United States
• Study site — Modesto, California, United States
• US Renal Care of Northridge — Northridge, California, United States
• Study site — Northridge, California, United States
• Norwalk Dialysis Center — Norwalk, California, United States
• Oakdale Kidney Center — Oakdale, California, United States
• US Renal Care of Panorama City — Panorama City, California, United States
• Mohammad Ismail MD, Inc. — Paramount, California, United States
• Azusa Dialysis Center — Azusa, California, United States

Full record on ClinicalTrials.gov

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