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
NCT ID: NCT01628120
Last Updated: 2019-03-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
170 participants
INTERVENTIONAL
2012-05-31
2015-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Epoetin Hospira
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.
Epoetin Hospira
Subcutaneous(SC) injection
Interventions
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Epoetin Hospira
Subcutaneous(SC) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Azusa Dialysis Center
Azusa, California, United States
Azusa, California, United States
Pegasus Dialysis
Bakersfield, California, United States
National Institute of Clinical Research
Bakersfield, California, United States
Bakersfield, California, United States
Bellflower Dialysis Center
Bellflower, California, United States
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
Long Beach, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
East LA Dialysis Center
Los Angeles, California, United States
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
Modesto, California, United States
US Renal Care of Northridge
Northridge, California, United States
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
Paramount Dialysis Center
Paramount, California, United States
Paramount, California, United States
Canyon Country Dialysis Center
Santa Clarita, California, United States
California Kidney Medical Group
Simi Valley, California, United States
US Renal Care of Van Nuys
Van Nuys, California, United States
intercommunity Dialysis Center
Whittier, California, United States
American Institute of Research
Whittier, California, United States
Whittier Kidney Dialysis Center
Whittier, California, United States
Whittier, California, United States
Kidney Center of Arvada
Arvada, Colorado, United States
Western Nephrology and Metabolic Bone Disease, PC
Arvada, Colorado, United States
Arvada, Colorado, United States
Kidney Center of westminster, LLC
Westminster, Colorado, United States
Western Nephrology and Metabolic Bone Disease, PC
Westminster, Colorado, United States
Westminster, Colorado, United States
Pines Clinical Research, Inc.
Pembroke Pines, Florida, United States
Pembroke Pines, Florida, United States
Nephrology Centers of America - Augusta (NCA-A)
Augusta, Georgia, United States
Augusta, Georgia, United States
Nephrology Centers of America (NCA) South Augusta
Augusta, Georgia, United States
Kidney Care Associates, LLC
Augusta, Georgia, United States
Grovetown Dialysis Center
Grovetown, Georgia, United States
East Macon Dialysis
Macon, Georgia, United States
Renal Physicians of Georgia, PC
Macon, Georgia, United States
Macon, Georgia, United States
Perry Dialysis Center
Perry, Georgia, United States
Waynesboro Dialysis Center
Waynesboro, Georgia, United States
Fresenius Medical Care Midtown #8498
Wichita, Kansas, United States
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, United States
Wichita, Kansas, United States
FMC Northside
Lafayette, Louisiana, United States
Research Nurse Specialists ,LLC
Lafayette, Louisiana, United States
Lafayette, Louisiana, United States
FMC Opelousas
Opelousas, Louisiana, United States
Fresenius Medical Care- Kalamazoo East
Kalamazoo, Michigan, United States
Fresenius Medical Care - Kalamazoo
Kalamazoo, Michigan, United States
Nephrology Center DBA Paragon Health PC
Kalamazoo, Michigan, United States
Kalamazoo, Michigan, United States
Fresenius Medical Care - Oshtermo
Kalamazoo, Michigan, United States
Fresenius Medical Care- Gull Road
Kalamazoo, Michigan, United States
Belton, Missouri, United States
Dialysis Clinics, Inc. - Belton
Belton, Missouri, United States
FMC Metro North Dialysis
Florissant, Missouri, United States
FMC Normandy Dialysis
Normandy, Missouri, United States
FMC St. Louis Regional Dialysis
Saint Ann, Missouri, United States
Metro Hypertension and Kidney Center
St Louis, Missouri, United States
St Louis, Missouri, United States
Dialysis Clinic Incorporated
North Brunswick, New Jersey, United States
North Brunswick, New Jersey, United States
Kennedy Dialysis Center
Sewell, New Jersey, United States
Kennedy Dialysis Center
Voorhees Township, New Jersey, United States
Voorhees Township, New Jersey, United States
College Point, New York, United States
Flushing, New York, United States
Trude Weishaupt Memorial Dialysis Center
Fresh Meadows, New York, United States
Wake Dialysis Clinic
Raleigh, North Carolina, United States
Wake Nephrology Associates, PA
Raleigh, North Carolina, United States
Raleigh, North Carolina, United States
DCI McMillan
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Innovative Dialysis of Toledo
Toledo, Ohio, United States
Toledo Hospital, Promedica Health System
Toledo, Ohio, United States
Toledo, Ohio, United States
Alexis Dialysis Center
Toledo, Ohio, United States
Wildwood Dialysis Center
Toledo, Ohio, United States
meadville Dialysis
Meadville, Pennsylvania, United States
The Center for Hypertension and Nephrology Care
Meadville, Pennsylvania, United States
Fresenius Medical Care
Knoxville, Tennessee, United States
Cedar Bluff Dialysis
Knoxville, Tennessee, United States
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, United States
Knoxville, Tennessee, United States
Fresenius Medical Care-Austin North Dialysis
Austin, Texas, United States
Research Management Inc.
Austin, Texas, United States
Research Management, Inc.
Austin, Texas, United States
Austin, Texas, United States
Fresenius Medical Care - Cedar Park
Cedar Park, Texas, United States
Grand Prairie Dialysis Center
Grand Prairie, Texas, United States
Grand Prairie, Texas, United States
Mission Bend Dialysis
Houston, Texas, United States
Southwest Houston Research, Ltd.
Houston, Texas, United States
Houston, Texas, United States
SNG Dialysis Center of Lufkin
Lufkin, Texas, United States
Lufkin, Texas, United States
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
San Antonio, Texas, United States
Las Palmas Davita Dialysis Center
San Antonio, Texas, United States
San Antonio, Texas, United States
ARA Mechanicsville Dialysis
Mechanicsville, Virginia, United States
Nephrology Specialists, P.C.
Mechanicsville, Virginia, United States
Mechanicsville, Virginia, United States
ARA South Laburnum Dialysis
Richmond, Virginia, United States
Countries
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References
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Wish JB, Rocha MG, Martin NE, Reyes CRD, Fishbane S, Smith MT, Nassar G. Long-term Safety of Epoetin Alfa-epbx for the Treatment of Anemia in ESKD: Pooled Analyses of Randomized and Open-label Studies. Kidney Med. 2019 Aug 28;1(5):271-280. doi: 10.1016/j.xkme.2019.06.009. eCollection 2019 Sep-Oct.
Other Identifiers
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C3461005
Identifier Type: OTHER
Identifier Source: secondary_id
EPOE-11-04
Identifier Type: -
Identifier Source: org_study_id
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