A Phase 3 Study Comparing the Effects of Subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
AiME - 13
A Therapeutic-equivalence Study Comparing The Efficacy And Safety Of Subcutaneous Epoetin Hospira And Epoetin Alfa (Amgen) In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment
2 other identifiers
interventional
320
1 country
73
Brief Summary
The purpose of this study is to demonstrate therapeutic equivalence of subcutaneous (SC) Epoetin Hospira compared to SC Epogen (Amgen), based on maintenance of hemoglobin (Hb) levels and study drug dose requirements 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 Jan 2012
73 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
First Submitted
Initial submission to the registry
November 2, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedStudy Start
First participant enrolled
January 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2014
CompletedResults Posted
Study results publicly available
June 20, 2018
CompletedAugust 9, 2018
July 1, 2018
2.1 years
November 2, 2011
May 16, 2018
July 12, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period
Week 30 up to Week 34
Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period
Week 30 up to Week 34
Secondary Outcomes (12)
Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period
Week 19 up to Week 34
Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period
Week 19 up to Week 34
Total Dose of Study Medication Administered: Maintenance Period
Week 19 up to Week 34
Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range: Maintenance Period
Week 26, 34
Percentage of Participants Who Required Permanent Dose Changes: Maintenance Period
Week 19 up to Week 34
- +7 more secondary outcomes
Other Outcomes (13)
Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL): Maintenance Period
Week 19 up to Week 34
Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL): Maintenance Period
Week 19 up to Week 34
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Titration Period: Week 1 up to Week 18 and Maintenance Period: Week 19 up to Week 38
- +10 more other outcomes
Study Arms (2)
Epoetin Hospira
EXPERIMENTALEpoetin Hospira
Epogen (Amgen)
ACTIVE COMPARATOREpogen (Amgen)
Interventions
Eligibility Criteria
You may qualify if:
- Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities
- Hemodialysis patients with chronic renal failure and renal anemia currently on stable Epogen (Amgen) dose administered IV or SC, 1 to 3 times per week for whom the following apply:
- A change in Epogen dosing of no more than 10% from the mean
- Mean hemoglobin between 9.0 and 11.0 g/dL
- No more than one hemoglobin result outside of range from 9.0-11.0 g/dL
- No hemoglobin result more than ±1 g/dL from the mean hemoglobin level
- Patients on stable, adequate dialysis for at least 12 weeks prior to randomization, defined as no clinically relevant changes of dialysis regimen and/or dialyzer
- Patients with adequate iron stores, defined as plasma ferritin \> 100 μg/L and TSAT \>20%, prior to randomization
- Male or female patients aged 18 to 80 years (both inclusive)
- If female, patient must be postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing at least one of the following methods of birth control:
- hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to randomization
- intrauterine device (IUD)
- 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 randomization. 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 dose
You may not qualify if:
- Maintenance epoetin dosage \>600 U/kg per week (1-3 times per week)
- Treatment with long-acting epoetin analogues such as Aranesp ® within 12 weeks prior to randomization
- Any of the following within 3 months prior to randomization:
- 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)
- Uncontrolled hypertension within the 4 weeks prior to randomization defined as more than 10% of post-dialysis blood pressures \>170 mmHg systolic and/or \>110 mmHg diastolic, based on blood pressure readings obtained when the patient's post-dialysis body weight was not more than 0.5 kg above their listed dry weight
- Known, clinically manifested deficiency of folic acid and/or vitamin B12 (irrespective of whether currently treated or not)
- A patient with any active, uncontrolled systemic, inflammatory or malignant disease that 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
- Contraindication for the test drug or have been previously treated with Epoetin Hospira
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Hospira, now a wholly owned subsidiary of Pfizercollaborator
Study Sites (73)
North America Research Institute
Azusa, California, 91702, United States
National Institute of Clinical Research
Bakersfield, California, 93309, United States
Long Beach Dialysis Center
Long Beach, California, 90813, United States
Academic Medical Research Institute
Los Angeles, California, 90022, United States
Long Beach Dialysis Center
Modesto, California, 95350, United States
Innovative Dialysis Center of Northridge, LLC
Northridge, California, 91324, United States
Valley Renal Medical Group
Northridge, California, 91324, United States
Research Management Inc.
Paramount, California, 90723, United States
Pleasanton Dialysis Center
Pleasanton, California, 94588, United States
Sunset Dialysis Center
Rancho Cordova, California, 95670, United States
Capital Nephrology Medical Group
Sacramento, California, 95825, United States
Chabot Nephrology Medical Group
San Leandro, California, 94578, United States
San Leandro Dialysis
San Leandro, California, 94578, United States
Renal Consultants Medical Group
Santa Clarita, California, 91387, 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
Western Nephrology and Metabolic Bone Disease, PC
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
Pines Clinical Research Inc.
Pembroke Pines, Florida, 33028, United States
Dialysis Clinic, Inc. - Albany
Albany, Georgia, 31701-2057, United States
Kidney Care Associates
Augusta, Georgia, 30909, United States
Renal Physicians of Georgia, PC
Dublin, Georgia, 31021, United States
Neomedica Marquette Park
Chicago, Illinois, 60636, United States
Research by Design, LLC
Evergreen Park, Illinois, 60805, United States
Kansas Nephrology Physicians, PA
Wichita, Kansas, 67214, United States
Research Nurse Specialists, LLC
Lafayette, Louisiana, 70503, United States
New York Harbor Health Care System
Lafayette, Louisiana, 70506, United States
Westbank Nephrology Associates
Marrero, Louisiana, 70072, United States
FMC Opelousas
Opelousas, Louisiana, 70570, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101, 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
Fresenius Medical Care-Oshtemo
Kalamazoo, Michigan, 49009, United States
Fresenius Medical Care-Gull Road
Kalamazoo, Michigan, 49048, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111, United States
Kansas City Renal Center
Kansas City, Missouri, 64111, United States
Renal Advantage, Inc.
Kansas City, Missouri, 64131, United States
Metro Hypertension and Kidney Center
St Louis, Missouri, 63136, United States
University of Cincinnati College of Medicine.
North Brunswick, New Jersey, 08902, United States
Nephrology & Hypertension Associates of NJ
Voorhees Township, New Jersey, 08043, United States
Newtown Dialysis Center
Astoria, New York, 11102, United States
New York Hospital Medical Center Queens Institutional Review Board
Flushing, New York, 11355, United States
Parker Jewish Institute for Health Care and Rehabilitation
New Hyde Park, New York, 11040, United States
New York Harbor Health Care System
New York, New York, 10010, United States
Wake Nephrology Associates, PA
Raleigh, North Carolina, 27609, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267, United States
Private Practice of Kenneth Lempert
Toledo, Ohio, 43606, United States
Northwest Physicians Associates, PC
Meadville, Pennsylvania, 16335, United States
CSRA Renal Services, LLC
Aiken, South Carolina, 29801, United States
Fresenius Medical Care Midtown JV
Columbia, South Carolina, 29201, United States
Columbia Nephrology Associates, PA
Columbia, South Carolina, 29203, United States
Fresenius Medical Care Irmo JV
Irmo, South Carolina, 29063, United States
South Carolina Nephrology and Hypertension Center, Inc.
Orangeburg, South Carolina, 29118, United States
Knoxville Kidney Center, PLLC
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
Dallas Veterans Affairs Medical Center
Dallas, Texas, 75216, United States
Grand Prairie Dialysis Center
Grand Prairie, Texas, 75051, United States
Research Across America
Houston, Texas, 77054, United States
Westminster Dialysis
Houston, Texas, 77077, United States
Mission Bend Dialysis
Houston, Texas, 77083, United States
Southwest Houston Research, Ltd.
Houston, Texas, 77099, United States
East Texas Nephrology Associates
Lufkin, Texas, 75904, United States
San Antonio Kidney Disease Center
San Antonio, Texas, 78229, United States
Renal Care Partners of Pentagon City
Arlington, Virginia, 22206, United States
Clinical Research and Consulting Center, LLC
Fairfax, Virginia, 22030, United States
Renal Care Partners of Fairfax
Fairfax, Virginia, 22030, United States
Nephrology Specialists, PC
Mechanicsville, Virginia, 23116, United States
Western Institutional Review Board
Olympia, Washington, 98502, United States
Related Publications (2)
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PMID: 36791280DERIVEDWish 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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
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
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2011
First Posted
November 17, 2011
Study Start
January 17, 2012
Primary Completion
February 28, 2014
Study Completion
February 28, 2014
Last Updated
August 9, 2018
Results First Posted
June 20, 2018
Record last verified: 2018-07