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
AiME - 04
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
2 other identifiers
interventional
170
1 country
115
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2012
Typical duration for phase_3
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2012
CompletedFirst Submitted
Initial submission to the registry
June 22, 2012
CompletedFirst Posted
Study publicly available on registry
June 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2015
CompletedResults Posted
Study results publicly available
July 19, 2018
CompletedMarch 18, 2019
February 1, 2019
2.7 years
June 22, 2012
May 21, 2018
February 27, 2019
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 (Hb) Levels
Baseline up to Week 48
- +5 more other outcomes
Study Arms (1)
Epoetin Hospira
EXPERIMENTALEpoetin 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.
Interventions
Subcutaneous(SC) 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 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.
- 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 (115)
Azusa Dialysis Center
Azusa, California, 91702, United States
Unknown Facility
Azusa, California, 91702, United States
Pegasus Dialysis
Bakersfield, California, 93308, United States
National Institute of Clinical Research
Bakersfield, California, 93309, United States
Unknown Facility
Bakersfield, California, 93309, United States
Bellflower Dialysis Center
Bellflower, California, 90706, United States
Unknown Facility
Granada Hills, California, 91344, United States
Lakewood Dialysis Center
Lakewood, California, 90712, United States
Westcoast Dialysis
Long Beach, California, 90806, United States
Long Beach Dialysis
Long Beach, California, 90813, United States
Novo Research
Long Beach, California, 90813, United States
Unknown Facility
Long Beach, California, 90813, United States
Academic Medical Research Institute
Los Angeles, California, 90022, United States
East LA Dialysis Center
Los Angeles, California, 90022, United States
Unknown Facility
Los Angeles, California, 90022, United States
Modesto Kidney Center
Modesto, California, 95350, United States
Novo Research, Inc. d/b/a Foundation Research
Modesto, California, 95350, United States
Parkway Kidney Center
Modesto, California, 95350, United States
Unknown Facility
Modesto, California, 95350, United States
US Renal Care of Northridge
Northridge, California, 91324, United States
Unknown Facility
Northridge, California, 91324, United States
Norwalk Dialysis Center
Norwalk, California, 90650, United States
Oakdale Kidney Center
Oakdale, California, 95361, United States
US Renal Care of Panorama City
Panorama City, California, 91402, United States
Mohammad Ismail MD, Inc.
Paramount, California, 90723, United States
Paramount Dialysis Center
Paramount, California, 90723, United States
Unknown Facility
Paramount, California, 90723, United States
Canyon Country Dialysis Center
Santa Clarita, California, 91387, United States
California Kidney Medical Group
Simi Valley, California, 93065, United States
US Renal Care of Van Nuys
Van Nuys, California, 91405, United States
intercommunity Dialysis Center
Whittier, California, 90602, United States
American Institute of Research
Whittier, California, 90603, United States
Whittier Kidney Dialysis Center
Whittier, California, 90603, United States
Unknown Facility
Whittier, California, 90603, United States
Kidney Center of Arvada
Arvada, Colorado, 80002, United States
Western Nephrology and Metabolic Bone Disease, PC
Arvada, Colorado, 80002, United States
Unknown Facility
Arvada, Colorado, 80002, United States
Kidney Center of westminster, LLC
Westminster, Colorado, 80031, United States
Western Nephrology and Metabolic Bone Disease, PC
Westminster, Colorado, 80031, United States
Unknown Facility
Westminster, Colorado, 80031, United States
Pines Clinical Research, Inc.
Pembroke Pines, Florida, 33028, United States
Unknown Facility
Pembroke Pines, Florida, 33028, United States
Nephrology Centers of America - Augusta (NCA-A)
Augusta, Georgia, 30901, United States
Unknown Facility
Augusta, Georgia, 30901, United States
Nephrology Centers of America (NCA) South Augusta
Augusta, Georgia, 30906, United States
Kidney Care Associates, LLC
Augusta, Georgia, 30909, United States
Grovetown Dialysis Center
Grovetown, Georgia, 30813, United States
East Macon Dialysis
Macon, Georgia, 31217, United States
Renal Physicians of Georgia, PC
Macon, Georgia, 31217, United States
Unknown Facility
Macon, Georgia, 31217, United States
Perry Dialysis Center
Perry, Georgia, 31069, United States
Waynesboro Dialysis Center
Waynesboro, Georgia, 30830, United States
Fresenius Medical Care Midtown #8498
Wichita, Kansas, 67214, United States
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, 67214, United States
Unknown Facility
Wichita, Kansas, 67214, United States
FMC Northside
Lafayette, Louisiana, 70501, United States
Research Nurse Specialists ,LLC
Lafayette, Louisiana, 70503, United States
Unknown Facility
Lafayette, Louisiana, 70506, United States
FMC Opelousas
Opelousas, Louisiana, 70570, United States
Fresenius Medical Care- Kalamazoo East
Kalamazoo, Michigan, 49001, United States
Fresenius Medical Care - Kalamazoo
Kalamazoo, Michigan, 49007, United States
Nephrology Center DBA Paragon Health PC
Kalamazoo, Michigan, 49007, United States
Unknown Facility
Kalamazoo, Michigan, 49007, United States
Fresenius Medical Care - Oshtermo
Kalamazoo, Michigan, 49009, United States
Fresenius Medical Care- Gull Road
Kalamazoo, Michigan, 49048, United States
Unknown Facility
Belton, Missouri, 64012, United States
Dialysis Clinics, Inc. - Belton
Belton, Missouri, 66012, United States
FMC Metro North Dialysis
Florissant, Missouri, 63033, United States
FMC Normandy Dialysis
Normandy, Missouri, 63121, United States
FMC St. Louis Regional Dialysis
Saint Ann, Missouri, 63074, United States
Metro Hypertension and Kidney Center
St Louis, Missouri, 63136, United States
Unknown Facility
St Louis, Missouri, 63136, United States
Dialysis Clinic Incorporated
North Brunswick, New Jersey, 08902, United States
Unknown Facility
North Brunswick, New Jersey, 08902, United States
Kennedy Dialysis Center
Sewell, New Jersey, 08080, United States
Kennedy Dialysis Center
Voorhees Township, New Jersey, 08043, United States
Unknown Facility
Voorhees Township, New Jersey, 08043, United States
Unknown Facility
College Point, New York, 11356, United States
Unknown Facility
Flushing, New York, 11355, United States
Trude Weishaupt Memorial Dialysis Center
Fresh Meadows, New York, 11365, United States
Wake Dialysis Clinic
Raleigh, North Carolina, 27609, United States
Wake Nephrology Associates, PA
Raleigh, North Carolina, 27609, United States
Unknown Facility
Raleigh, North Carolina, 27609, United States
DCI McMillan
Cincinnati, Ohio, 45206, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Innovative Dialysis of Toledo
Toledo, Ohio, 43606, United States
Toledo Hospital, Promedica Health System
Toledo, Ohio, 43606, United States
Unknown Facility
Toledo, Ohio, 43606, United States
Alexis Dialysis Center
Toledo, Ohio, 43613, United States
Wildwood Dialysis Center
Toledo, Ohio, 43615, United States
meadville Dialysis
Meadville, Pennsylvania, 16335, United States
The Center for Hypertension and Nephrology Care
Meadville, Pennsylvania, 16335, United States
Fresenius Medical Care
Knoxville, Tennessee, 37921, United States
Cedar Bluff Dialysis
Knoxville, Tennessee, 37923, United States
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, 37923, United States
Unknown Facility
Knoxville, Tennessee, 37923, United States
Fresenius Medical Care-Austin North Dialysis
Austin, Texas, 78758, United States
Research Management Inc.
Austin, Texas, 78758, United States
Research Management, Inc.
Austin, Texas, 78758, United States
Unknown Facility
Austin, Texas, 78758, United States
Fresenius Medical Care - Cedar Park
Cedar Park, Texas, 78613, United States
Grand Prairie Dialysis Center
Grand Prairie, Texas, 75051, United States
Unknown Facility
Grand Prairie, Texas, 75051, United States
Mission Bend Dialysis
Houston, Texas, 77083, United States
Southwest Houston Research, Ltd.
Houston, Texas, 77099, United States
Unknown Facility
Houston, Texas, 77099, United States
SNG Dialysis Center of Lufkin
Lufkin, Texas, 75904, United States
Unknown Facility
Lufkin, Texas, 75904, United States
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
San Antonio, Texas, 78229, United States
Las Palmas Davita Dialysis Center
San Antonio, Texas, 78237, United States
Unknown Facility
San Antonio, Texas, 78237, United States
ARA Mechanicsville Dialysis
Mechanicsville, Virginia, 23116, United States
Nephrology Specialists, P.C.
Mechanicsville, Virginia, 23116, United States
Unknown Facility
Mechanicsville, Virginia, 23116, United States
ARA South Laburnum Dialysis
Richmond, Virginia, 23231, United States
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
May 31, 2012
Primary Completion
February 13, 2015
Study Completion
February 13, 2015
Last Updated
March 18, 2019
Results First Posted
July 19, 2018
Record last verified: 2019-02