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
- Conditions
- Chronic Renal Failure Requiring Hemodialysis
- Interventions
- Biological: Epoetin Hospira
- Registration Number
- NCT01628107
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 406
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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.
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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.
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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.
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Adequate methods of contraception to prevent pregnancy are to be maintained throughout the course of the study in both male and female study subjects.
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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.
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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)
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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.
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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.
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A female patient who is pregnant, lactating, or planning a pregnancy during the study.
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History of drug abuse or alcohol abuse during the core study prior to enrollment as determined by the Investigator.
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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).
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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.
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Epoetin Hospira Epoetin Hospira Epoetin Hospira will be administered by IV 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 24 Week 13 up to Week 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.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 48 Week 1 up to Week 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.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 48 Week 37 up to Week 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.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 12 Week 1 up to Week 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.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Week 1 Up through 7 days after first dose of study drug (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.
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 36 Week 25 up to Week 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.
- Secondary Outcome Measures
Name Time Method 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 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 Hematocrit is defined as the percentage of red blood cells in the blood.
Mean Weekly Dosage of Epoetin Hospira : Over Week 1 to 48 Week 1 up to Week 48 Mean Hematocrit Levels: Over Week 1 to 48 Week 1 up to Week 48 Hematocrit is defined as the percentage of red blood cells in the blood.
Percentage of Participants With Hemoglobin Level Outside the Target Range Week 1 up to Week 48 Percentage of participants with hemoglobin level outside the target range of 9.0 to 11.0 g/dL were reported.
Percentage of Participants Who Received Blood Transfusions Week 1 up to Week 48
Trial Locations
- Locations (107)
Coconut Creek Dialysis JV
🇺🇸Margate, Florida, United States
American Renal Associates Naples Dialysis Center
🇺🇸Naples, Florida, United States
Tamarac Kidney Center
🇺🇸Tamarac, Florida, United States
Clinton Township Dialysis
🇺🇸Clinton Township, Michigan, United States
Biloxi Dialysis
🇺🇸Biloxi, Mississippi, United States
FMC/South Mississippi Kidney Center of Gulfport
🇺🇸Gulfport, Mississippi, United States
Fresenius Medical Care·Humacao
🇵🇷Humacao, Puerto Rico
Sumter Dialysis Clinic
🇺🇸Sumter, South Carolina, United States
Consolidated Medical Plaza
🇵🇷Caguas, Puerto Rico
Renal Consultants Medical Group
🇺🇸Granada Hills, California, United States
Advanced Medical Research (Administrative)
🇺🇸Lakewood, California, United States
Imperial Care Dialysis Center
🇺🇸Lynwood, California, United States
Modesto Kidney Center
🇺🇸Modesto, California, United States
Sierra View Dialysis Center
🇺🇸Porterville, California, United States
Westcoast Dialysis
🇺🇸Long Beach, California, United States
Parkway Kindey Center
🇺🇸Modesto, California, United States
Long Beach Clinical Trials
🇺🇸Long Beach, California, United States
South Mississippi Medical Research, PLLC
🇺🇸Gulfport, Mississippi, United States
Sierra View District Hospital Dialysis Center
🇺🇸Porterville, California, United States
South Florida Research Institute
🇺🇸Laureda Lake, Florida, United States
Long Beach Dialysis
🇺🇸Long Beach, California, United States
Sierra View Nephrology, Inc.
🇺🇸Porterville, California, United States
Santa Fe Springs Dialysis
🇺🇸Whittier, California, United States
Nephrology and Hypertension Associates,PC
🇺🇸Middlebury, Connecticut, United States
Florida Kidney Center
🇺🇸Lauderhill, Florida, United States
Discovery Medical Research Group, Inc.
🇺🇸Ocala, Florida, United States
Ocala Regional Kidney Center, East
🇺🇸Ocala, Florida, United States
Gamma Medical Research Inc.
🇺🇸Edinburg, Texas, United States
Chromalloy American Kidney Center Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Ong, Rubin, Shahmir A Medical Corp DBA: Solano Kidney Care
🇺🇸Fairfield, California, United States
North America Research Institute
🇺🇸Azusa, California, United States
Santa Clarita Kidney Center
🇺🇸Valencia, California, United States
Innovative Medical Research of South Florida, Inc,
🇺🇸Aventura, Florida, United States
West Boca Dialysis Center
🇺🇸Boca Raton, Florida, United States
Ft. Lauderdale Kidney Center
🇺🇸Plantation, Florida, United States
Plantation Kidney Center
🇺🇸Plantation, Florida, United States
Liberty Dialysis/Boise Kidney & Hypertension Institute
🇺🇸Nampa, Idaho, United States
Asheville Kidney Center
🇺🇸Asheville, North Carolina, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Fresenius Medical Care- Mt. Airy Kidney Center
🇺🇸Philadelphia, Pennsylvania, United States
Fresenius Greater Columbus Regional Dialysis Center
🇺🇸Columbus, Ohio, United States
HNC Dialysis, Ltd.
🇺🇸Columbus, Ohio, United States
Delaware Valley Nephrology and Hypertension Associates, PC
🇺🇸Philadelphia, Pennsylvania, United States
AnMed Health
🇺🇸Anderson, South Carolina, United States
Fresenius Medical Care - Olney Dialysis Center
🇺🇸Philadelphia, Pennsylvania, United States
Columbia Nephrology Associates, P. A.
🇺🇸Columbia, South Carolina, United States
Columbia Nephrology Associates, PA
🇺🇸Columbia, South Carolina, United States
Fresenius Medical Care Columbia JV
🇺🇸Columbia, South Carolina, United States
Fresenius Medical Care Meadowlake JV
🇺🇸Columbia, South Carolina, United States
Anderson Dialysis Clinic
🇺🇸Anderson, South Carolina, United States
Nephrology and Internal Medicine of Anderson
🇺🇸Anderson, South Carolina, United States
Fresenius Medical Care South Columbia JV
🇺🇸Columbia, South Carolina, United States
Fresenius Medical Care SE Columbia JV
🇺🇸Columbia, South Carolina, United States
Med Center Dialysis
🇺🇸Houston, Texas, United States
Fresenius Medical Care Kidney Center
🇺🇸Houston, Texas, United States
Southwest Houston Dialysis
🇺🇸Houston, Texas, United States
Grosse Pointe Dialysis
🇺🇸Detroit, Michigan, United States
Renaissance Renal Research Institute, LLC
🇺🇸Detroit, Michigan, United States
Novo Research d/b/a Foundation Research
🇺🇸Modesto, California, United States
Ontario Dialysis Center
🇺🇸Ontario, California, United States
North Suburban Nephrology, LLC
🇺🇸Gurnee, Illinois, United States
ECU Nephrology and Hypertension
🇺🇸Greenville, North Carolina, United States
Lower Manhattan Dialysis Center II
🇺🇸New York, New York, United States
Cincinnati VA Medical Center
🇺🇸Cincinnati, Ohio, United States
Meyerland Dialysis
🇺🇸Houston, Texas, United States
Millennium Clinical Research, Inc.
🇺🇸Houston, Texas, United States
DaVita North Park
🇺🇸Houston, Texas, United States
North Shepherd Dialysis Center
🇺🇸Houston, Texas, United States
Southwest Houston Research, Ltd.
🇺🇸Houston, Texas, United States
Fresenius Medical Care McAllen
🇺🇸McAllen, Texas, United States
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
🇺🇸San Antonio, Texas, United States
Floyd Curl DaVita Dialysis Center
🇺🇸San Antonio, Texas, United States
National Institute of Clinical Research
🇺🇸Ontario, California, United States
Bellflower Dialysis Center
🇺🇸Bellflower, California, United States
Davita - South Valley Dialysis
🇺🇸Encino, California, United States
DaVita Premier Dialysis Center
🇺🇸Cudahy, California, United States
Fairfield Dialysis Center
🇺🇸Fairfield, California, United States
DaVita Bixby Knolls Dialysis
🇺🇸Long Beach, California, United States
Nephrology Educational Services and Research, Inc
🇺🇸Tarzana, California, United States
Oakdale Kidney Center
🇺🇸Oakdale, California, United States
American Institute of Research
🇺🇸Whittier, California, United States
Physicians Dialysis of North Beach
🇺🇸North Miami Beach, Florida, United States
Innovative Medical Research of South Florida, Inc.
🇺🇸North Miami Beach, Florida, United States
Silver Springs Shores Dialysis Center
🇺🇸Ocala, Florida, United States
Dialysis of Dublin
🇺🇸Dublin, Georgia, United States
Pacific Renal Research Institute/Boise Kidney & Hypertension Institute
🇺🇸Meridian, Idaho, United States
FMC Ross Englewood Dialysis
🇺🇸Chicago, Illinois, United States
Neomedica South
🇺🇸Chicago, Illinois, United States
Research by Design, LLC
🇺🇸Evergreen Park, Illinois, United States
Mountain Kidney and Hypertension Associates, P A
🇺🇸Asheville, North Carolina, United States
Barnes-Jewish Dialysis Center
🇺🇸Saint Louis, Missouri, United States
Butler Farm Dialysis
🇺🇸Hampton, Virginia, United States
Dialysis Center of Lubbock
🇺🇸Lubbock, Texas, United States
Neomedica Round Lake
🇺🇸Round Lake, Illinois, United States
United Dialysis Center
🇺🇸Long Beach, California, United States
Kidney Research Center
🇺🇸Lynwood, California, United States
Paramount Dialysis Center
🇺🇸Paramount, California, United States
Sierra View District Hospital
🇺🇸Porterville, California, United States
Fresenius Medial Care Mission
🇺🇸Mission, Texas, United States
Neomedica Evergreen Park
🇺🇸Evergreen Park, Illinois, United States
Missouri City Dialysis
🇺🇸Missouri City, Texas, United States
NW Medical Center DaVita Dialysis
🇺🇸San Antonio, Texas, United States
Peninsula Kidney Associates
🇺🇸Hampton, Virginia, United States
Renal Physicians of Georgia, PC
🇺🇸Dublin, Georgia, United States
Waterbury Dialysis Center
🇺🇸Waterbury, Connecticut, United States
Greater Waterbury Dialysis
🇺🇸Waterbury, Connecticut, United States
Discovery Medical Research Group, Inc.,
🇺🇸Ocala, Florida, United States