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
AiME - 03
A Phase III, Open-label, Multicenter, Long-term Safety Study Of Intravenous Epoetin Hospira In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment
2 other identifiers
interventional
406
2 countries
110
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2012
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2012
CompletedFirst Posted
Study publicly available on registry
June 26, 2012
CompletedStudy Start
First participant enrolled
July 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2015
CompletedResults Posted
Study results publicly available
July 19, 2018
CompletedJuly 19, 2018
June 1, 2018
2.5 years
June 22, 2012
May 21, 2018
June 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Percentage of Participants With Treatment Emergent Adverse Events (AEs): 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.
Up through 7 days after first dose of study drug (Week 1)
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 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.
Week 1 up to Week 12
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 13 to 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.
Week 13 up to Week 24
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 25 to 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.
Week 25 up to Week 36
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 37 to 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.
Week 37 up to Week 48
Percentage of Participants With Treatment Emergent Adverse Events (AEs): Over Week 1 to 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.
Week 1 up to Week 48
Secondary Outcomes (8)
Mean Weekly Dosage of Epoetin Hospira : Over Week 1 to 48
Week 1 up to Week 48
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: Over Week 1 to 48
Week 1 up to Week 48
- +3 more secondary outcomes
Other Outcomes (8)
Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)
Week 1 up to Week 48
Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)
Week 1 up to Week 48
Number of Participants With Clinically Significant Change From Baseline in Hemoglobin Levels
Baseline up to Week 48
- +5 more other outcomes
Study Arms (1)
Epoetin Hospira
EXPERIMENTALEpoetin 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.
Interventions
Intravenous (IV) injection
Eligibility Criteria
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 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.
- 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.
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (110)
North America Research Institute
Azusa, California, 91702, United States
Bellflower Dialysis Center
Bellflower, California, 90706, United States
National Institute of Clinical Research
Commerce, California, 90040, United States
DaVita Premier Dialysis Center
Cudahy, California, 90201, United States
Davita - South Valley Dialysis
Encino, California, 91316, United States
Ong, Rubin, Shahmir A Medical Corp DBA: Solano Kidney Care
Fairfield, California, 94533, United States
Fairfield Dialysis Center
Fairfield, California, 94534, United States
Renal Consultants Medical Group
Granada Hills, California, 91344, United States
Advanced Medical Research (Administrative)
Lakewood, California, 90712, United States
Long Beach Clinical Trials
Long Beach, California, 90806, United States
Westcoast Dialysis
Long Beach, California, 90806, United States
DaVita Bixby Knolls Dialysis
Long Beach, California, 90807, United States
United Dialysis Center
Long Beach, California, 90807, United States
Long Beach Dialysis
Long Beach, California, 90813, United States
Imperial Care Dialysis Center
Lynwood, California, 90262, United States
Kidney Research Center
Lynwood, California, 90262, United States
Modesto Kidney Center
Modesto, California, 95350, United States
Novo Research d/b/a Foundation Research
Modesto, California, 95350, United States
Parkway Kindey Center
Modesto, California, 95350, United States
Oakdale Kidney Center
Oakdale, California, 95361, United States
National Institute of Clinical Research
Ontario, California, 91762, United States
Ontario Dialysis Center
Ontario, California, 91762, United States
Paramount Dialysis Center
Paramount, California, 90723, United States
Sierra View Dialysis Center
Porterville, California, 93257, United States
Sierra View District Hospital Dialysis Center
Porterville, California, 93257, United States
Sierra View District Hospital
Porterville, California, 93257, United States
Sierra View Nephrology, Inc.
Porterville, California, CA, United States
Nephrology Educational Services and Research, Inc
Tarzana, California, 91356, United States
Santa Clarita Kidney Center
Valencia, California, 91355, United States
American Institute of Research
Whittier, California, 90603, United States
Santa Fe Springs Dialysis
Whittier, California, 90606, United States
Nephrology and Hypertension Associates,PC
Middlebury, Connecticut, 06762, United States
Waterbury Dialysis Center
Waterbury, Connecticut, 06705, United States
Greater Waterbury Dialysis
Waterbury, Connecticut, 06708, United States
Innovative Medical Research of South Florida, Inc,
Aventura, Florida, 33180, United States
West Boca Dialysis Center
Boca Raton, Florida, 33434, United States
Florida Kidney Center
Lauderhill, Florida, 33319, United States
South Florida Research Institute
Laureda Lake, Florida, 33313, United States
Coconut Creek Dialysis JV
Margate, Florida, 33063, United States
American Renal Associates Naples Dialysis Center
Naples, Florida, 34119, United States
Innovative Medical Research of South Florida, Inc.
North Miami Beach, Florida, 33169, United States
Physicians Dialysis of North Beach
North Miami Beach, Florida, 33169, United States
Discovery Medical Research Group, Inc.,
Ocala, Florida, 34471, United States
Discovery Medical Research Group, Inc.
Ocala, Florida, 34471, United States
Ocala Regional Kidney Center, East
Ocala, Florida, 34471, United States
Silver Springs Shores Dialysis Center
Ocala, Florida, 34472, United States
Ft. Lauderdale Kidney Center
Plantation, Florida, 33312, United States
Plantation Kidney Center
Plantation, Florida, 33324, United States
Tamarac Kidney Center
Tamarac, Florida, 33321, United States
Dialysis of Dublin
Dublin, Georgia, 31021, United States
Renal Physicians of Georgia, PC
Dublin, Georgia, 31021, United States
Liberty Dialysis/Boise Kidney & Hypertension Institute
Caldwell, Idaho, 83605, United States
Liberty Dialysis/Boise Kidney & Hypertension Institute
Meridian, Idaho, 83642, United States
Pacific Renal Research Institute/Boise Kidney & Hypertension Institute
Meridian, Idaho, 83642, United States
Liberty Dialysis/Boise Kidney & Hypertension Institute
Nampa, Idaho, 83686, United States
Neomedica South
Chicago, Illinois, 60617, United States
FMC Ross Englewood Dialysis
Chicago, Illinois, 60621, United States
Neomedica Evergreen Park
Evergreen Park, Illinois, 60805, United States
Research by Design, LLC
Evergreen Park, Illinois, 60805, United States
North Suburban Nephrology, LLC
Gurnee, Illinois, 60031, United States
Neomedica Round Lake
Round Lake, Illinois, 60073, United States
Clinton Township Dialysis
Clinton Township, Michigan, 48038, United States
Grosse Pointe Dialysis
Detroit, Michigan, 48224, United States
Renaissance Renal Research Institute, LLC
Detroit, Michigan, 48236, United States
Biloxi Dialysis
Biloxi, Mississippi, 39530, United States
FMC/South Mississippi Kidney Center of Gulfport
Gulfport, Mississippi, 39501, United States
South Mississippi Medical Research, PLLC
Gulfport, Mississippi, 39501, United States
Barnes-Jewish Dialysis Center
St Louis, Missouri, 63108, United States
Chromalloy American Kidney Center Washington University School of Medicine
St Louis, Missouri, 63110, United States
Lower Manhattan Dialysis Center II
New York, New York, 10003, United States
Mountain Kidney and Hypertension Associates, P A
Asheville, North Carolina, 28801, United States
Asheville Kidney Center
Asheville, North Carolina, 28805, United States
ECU Nephrology and Hypertension
Greenville, North Carolina, 27834-2847, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220, United States
Fresenius Greater Columbus Regional Dialysis Center
Columbus, Ohio, 43215, United States
HNC Dialysis, Ltd.
Columbus, Ohio, 43215, United States
Delaware Valley Nephrology and Hypertension Associates, PC
Philadelphia, Pennsylvania, 19118, United States
Fresenius Medical Care- Mt. Airy Kidney Center
Philadelphia, Pennsylvania, 19118, United States
Fresenius Medical Care - Olney Dialysis Center
Philadelphia, Pennsylvania, 19138, United States
Anderson Dialysis Clinic
Anderson, South Carolina, 29621, United States
AnMed Health
Anderson, South Carolina, 29621, United States
Nephrology and Internal Medicine of Anderson
Anderson, South Carolina, 29621, United States
Columbia Nephrology Associates, P. A.
Columbia, South Carolina, 29203, United States
Columbia Nephrology Associates, PA
Columbia, South Carolina, 29203, United States
Fresenius Medical Care Columbia JV
Columbia, South Carolina, 29203, United States
Fresenius Medical Care Meadowlake JV
Columbia, South Carolina, 29203, United States
Fresenius Medical Care South Columbia JV
Columbia, South Carolina, 29203, United States
Fresenius Medical Care SE Columbia JV
Columbia, South Carolina, 29209, United States
Sumter Dialysis Clinic
Sumter, South Carolina, 29150, United States
Gamma Medical Research Inc.
Edinburg, Texas, 78539, United States
Med Center Dialysis
Houston, Texas, 77004, United States
Fresenius Medical Care Kidney Center
Houston, Texas, 77030, United States
Meyerland Dialysis
Houston, Texas, 77035, United States
Millennium Clinical Research, Inc.
Houston, Texas, 77054, United States
Southwest Houston Dialysis
Houston, Texas, 77071, United States
DaVita North Park
Houston, Texas, 77073, United States
North Shepherd Dialysis Center
Houston, Texas, 77091, United States
Southwest Houston Research, Ltd.
Houston, Texas, 77099, United States
Dialysis Center of Lubbock
Lubbock, Texas, 79430, United States
Fresenius Medical Care McAllen
McAllen, Texas, 78503, United States
Fresenius Medial Care Mission
Mission, Texas, 78572, United States
Missouri City Dialysis
Missouri City, Texas, 77489, United States
NW Medical Center DaVita Dialysis
San Antonio, Texas, 78229, United States
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
San Antonio, Texas, 78229, United States
Floyd Curl DaVita Dialysis Center
San Antonio, Texas, 78240, United States
Butler Farm Dialysis
Hampton, Virginia, 23666, United States
Peninsula Kidney Associates
Hampton, Virginia, 23666, United States
Consolidated Medical Plaza
Caguas, 00725, Puerto Rico
Fresenius Medical Care·Humacao
Humacao, 00791, Puerto Rico
Related Publications (1)
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.
PMID: 32734207DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer, Inc.
- Organization
- Pfizer ClinicalTrials.gov Call Center
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2012
First Posted
June 26, 2012
Study Start
July 16, 2012
Primary Completion
January 2, 2015
Study Completion
January 2, 2015
Last Updated
July 19, 2018
Results First Posted
July 19, 2018
Record last verified: 2018-06