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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

Information source: Hospira, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Renal Failure Requiring Hemodialysis

Intervention: Epoetin Hospira (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Hospira, Inc.

Summary

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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Treatment emergent adverse events

Secondary outcome:

Mean weekly epoetin dosage

Mean hemoglobin levels

Mean hematocrit levels

Proportion of patients with Hgb measurement outside the target range

Percentage of patients receiving blood transfusions

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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 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. 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.

Locations and Contacts

Azusa, California 91702, United States

Bakersfield, California 93309, United States

Granada Hills, California 91344, United States

Long Beach, California 90813, United States

Los Angeles, California 90022, United States

Modesto, California 95350, United States

Northridge, California 91324, United States

Paramount, California 90723, United States

Whittier, California 90603, United States

Arvada, Colorado 80002, United States

Westminster, Colorado 80031, United States

Pembroke Pines, Florida 33028, United States

Augusta, Georgia 30901, United States

Macon, Georgia 31217, United States

Wichita, Kansas 67214, United States

Lafayette, Louisiana 70506, United States

Kalamazoo, Michigan 49007, United States

Belton, Missouri 64012, United States

Saint Louis, Missouri 63136, United States

North Brunswick, New Jersey 08902, United States

Voorhees, New Jersey 08043, United States

College Point, New York 11356, United States

Flushing, New York 11355, United States

Raleigh, North Carolina 27609, United States

Cincinnati, Ohio 45267, United States

Toledo, Ohio 43606, United States

Knoxville, Tennessee 37923, United States

Austin, Texas 78758, United States

Grand Prarie, Texas 75051, United States

Houston, Texas 77099, United States

Lufkin, Texas 75904, United States

San Antonio, Texas 78237, United States

Mechanicsville, Virginia 23116, United States

Additional Information

Starting date: May 2012
Last updated: June 12, 2015

Page last updated: August 23, 2015

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