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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

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

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.

Clinical Details

Official title: A Phase 3, Open-Label, Multicenter, Long-Term Safety Study of Intravenous 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:

Epoetin dosage per body weight

Mean hemoglobin levels

Mean hematocrit levels

Proportion of patients with Hgb measurement outside 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 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.

Locations and Contacts

Caguas 00725, Puerto Rico

Fairfield, California 94533, United States

Glendale, California 91204, United States

Granada Hills, California 91344, United States

Lakewood, California 90712, United States

Long Beach, California 90807, United States

Los Angeles, California 90022, United States

Modesto, California 95350, United States

Northridge, California 91324, United States

Ontario, California 91762, United States

Porterville, California 93257, United States

Tarzana, California 91356, United States

Whittier, California 90603, United States

Whittier, California 90606, United States

Yuba City, California 95991, United States

Lauderdale Lakes, Florida 33313, United States

Naples, Florida 34119, United States

North Miami, Florida 33169, United States

Ocala, Florida 34471, United States

Dublin, Georgia 31021, United States

Meridian, Idaho 83642, United States

Evergreen Park, Illinois 60805, United States

Gurnee, Illinois 60031, United States

Detroit, Michigan 48236-2152, United States

Gulfport, Mississippi 39501, United States

Saint Louis, Missouri 63110, United States

New York, New York 10016, United States

Ashville, North Carolina 28801, United States

Greenville, North Carolina 27834, United States

Cincinnati, Ohio 45220, United States

Columbus, Ohio 43215, United States

Anderson, South Carolina 29621, United States

Columbia, South Carolina 29203, United States

Orangeburg, South Carolina 29118, United States

Sumter, South Carolina 29150, United States

Arlington, Texas 76015, United States

Greenville, Texas 75402, United States

Houston, Texas 77054-1180, United States

Houston, Texas 77054-11081, United States

Houston, Texas 77099, United States

Houston, Texas 77004, United States

Lubbock, Texas 79430, United States

Mc Allen, Texas 78503, United States

Mission, Texas 78572, United States

San Antonio, Texas 78229, United States

Hampton, Virginia 23666, United States

Additional Information

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

Page last updated: August 23, 2015

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