A Phase 3 Study Comparing the Effects of Intravenous 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 - 01
A Therapeutic-equivalence Study Comparing The Efficacy And Safety Of Intravenous Epoetin Hospira And Epoetin Alfa (Amgen) In Patients With Chronic Renal Failure Requiring Hemodialysis And Receiving Epoetin Maintenance Treatment
2 other identifiers
interventional
612
2 countries
85
Brief Summary
The purpose of this study is to demonstrate therapeutic equivalence of IV Epoetin Hospira compared to IV Epogen (Amgen), based on maintenance of 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 P75+ for phase_3
Started Jan 2012
85 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 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 11, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 11, 2014
CompletedResults Posted
Study results publicly available
July 13, 2018
CompletedSeptember 10, 2018
August 1, 2018
2 years
November 2, 2011
May 21, 2018
August 9, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Mean Weekly Hemoglobin Level From Week 21 to Week 24
Week 21 up to Week 24
Mean Weekly Dosage of Study Medication From Week 21 to Week 24
Week 21 up to Week 24
Secondary Outcomes (11)
Mean Weekly Hemoglobin Level Through 24 Weeks
Week 1 up to Week 24
Mean Weekly Dosage of Study Medication Through 24 Weeks
Week 1 up to Week 24
Total Dose of Study Medication Administered
Week 1 up to Week 24
Percentage of Participants With Mean Weekly Hemoglobin Level Within the Target Range
Week 12, 24
Percentage of Participants Who Required Permanent Dose Changes of Study Medication
Week 1 up to Week 24
- +6 more secondary outcomes
Other Outcomes (11)
Percentage of Participants With Hemoglobin Level Less Than (<) 8.0 Gram Per Deciliter (g/dL)
Week 1 up to Week 24
Percentage of Participants With Hemoglobin Level Greater Than (>) 12.0 Gram Per Deciliter (g/dL)
Week 1 up to Week 24
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Week 1 up to Week 28
- +8 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) treatment for at least 4 weeks prior to randomization, for whom the following apply (during this period):
- Epogen (Amgen) dose has been administered intravenously 1 to 3 times per week with no more than a 10% dose change from the mean for at least 4 weeks prior to randomization
- Stable hemoglobin, defined as meeting all of the following:
- Mean hemoglobin during the 4 weeks prior to randomization between 9.0 and 11.0 g/dL
- No more than one hemoglobin outside of range from 9.0-11.0 g/dL during the 4 weeks prior to randomization
- No hemoglobin result more than ±1 g/dL from the mean hemoglobin level during the 4 week period prior to randomization
- 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 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 either postmenopausal for at least 1 year prior to randomization, 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 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 3 months 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 (including demyelinating diseases such as multiple sclerosis) that in the Investigator's opinion may be significant to exclude participation in the study, including but not limited to 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 (85)
Montgomery Kidney Specialists
Montgomery, Alabama, 36106, United States
Southwest Clinical Research Institute, LLC
Tempe, Arizona, 85284, United States
Lakhi M. Sakhrani, MD A Medical Coporation
Alhambra, California, 91801, United States
North America Research Institute
Azusa, California, 91702, United States
DaVita Dialysis Center-Bakersfield Dialysis Center
Bakersfield, California, 93309, United States
Ong, Rubin, Shahmir A Medical Corp DBA: Solano Kidney Care
Fairfield, California, 94533, United States
A Medical Corporation
Glendale, California, 91204, United States
Renal Consultants Medical Group
Granada Hills, California, 91344, United States
La Puente Dialysis Center
La Puente, California, 91744, United States
Advanced Medical Research, LLC
Lakewood, California, 90712, United States
DaVita Bixby Knolls Dialysis
Long Beach, California, 90807, United States
Bayview Nephrology, Inc
Long Beach, California, 90813, United States
Academic Medical Research Institute
Los Angeles, California, 90022, United States
Desert Nephrology Medical Group
Modesto, California, 95350, United States
La Jolla Clinical Research, Inc.
National City, California, 91950, United States
Valley Renal Medical Group
Northridge, California, 91324, United States
Ontario Dialysis Inc
Ontario, California, 91762, United States
Discovery medical Research Group, Inc.
Porterville, California, 93257, United States
Nephrology Educational Services and Research, Inc
Tarzana, California, 91356, United States
Queen Dialysis Center
West Covina, California, 91790, United States
American Institute of Research
Whittier, California, 90603, United States
Mark C. Lee, Inc. Santa Fe Springs Dialysis
Whittier, California, 90606, United States
North Valley Nephrology
Yuba City, California, 95991, United States
Nephrology and Hypertension Associates
Middlebury, Connecticut, 06762, United States
South Florida Nephrology, Inc.
Coral Springs, Florida, 33071, United States
South Florida Research Institute
Lauderdale Lakes, Florida, 33313, United States
San Marcus Research Clinic, Inc
Miami, Florida, 33015, United States
Nephrology Associates of South Miami
Miami, Florida, 33173, United States
ARA Naples South Dialysis Center
Naples, Florida, 34112-6703, United States
ARA- Naples Dialysis Center, LLC
Naples, Florida, 34119, United States
Innovative Medical Research of South Florida, Inc.
North Miami Beah, Florida, 33169, United States
Discovery Medical Research Group, Inc.
Ocala, Florida, 34471, United States
Central Florida Kidney Centers
Orlando, Florida, 32801-3621, United States
Renal Physicians of Georgia, PC
Dublin, Georgia, 31021, United States
Boise Kidney & Hypertension Institute, PLLC
Meridian, Idaho, 83642, United States
Research by Design, LLC
Evergreen Park, Illinois, 60805, United States
North Suburban Nephrology, LLC
Gurnee, Illinois, 60031, United States
Nephrology Specialists, PC
Merrillville, Indiana, 46410, United States
Westbank Nephrology Associates
Marrero, Louisiana, 70072, United States
Internal Medicine Specialists
New Orleans, Louisiana, 70115, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101, United States
DaVita Dialysis Centers
Clinton Township, Michigan, 48038, United States
St. Clair Specialty Physicians, P.C.
Detroit, Michigan, 48236, United States
South Mississippi Medical Research, PLLC
Gulfport, Mississippi, 39501, United States
Chromalloy American Kidney Center
St Louis, Missouri, 63110, United States
Kidney Specialists of Southern Nevada
Las Vegas, Nevada, 89106, United States
Hypertension & Nephrology Associates
Eatontown, New Jersey, 07724, United States
Brookdale Physician Dialysis Associates
Brooklyn, New York, 11212, United States
Lower Manhattan Dialysis Center
New York, New York, 10016, United States
Mountain Kidney and Hypertension Associates, PA
Asheville, North Carolina, 28801, United States
East Carolina University, ECU School of Medicine, Department of Internal Medicine
Greenville, North Carolina, 27834, United States
Eastern Nephrology Associates, PLLC
New Bern, North Carolina, 28562, United States
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, 27103, United States
Cincinnati VA Medical Center
Cincinnati, Ohio, 45220, United States
HNC Dialysis Ltd.
Columbus, Ohio, 43215, United States
Bayview Nephrology, Inc
Erie, Pennsylvania, 16507, United States
DaVita-Erie Dialysis Center
Erie, Pennsylvania, 16507, United States
UPMC Hamot Clinical Trials Department
Erie, Pennsylvania, 16507, United States
Franklin Dialysis Center
Philadelphia, Pennsylvania, 19106, United States
Delaware Valley Nephrology and Hypertension Associates, PC
Philadelphia, Pennsylvania, 19118, 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
Palmetto Nephrology, PA
Orangeburg, South Carolina, 29118, United States
South Carolina Nephrology and Hypertension Center, Inc.
Orangeburg, South Carolina, 29118, United States
Desert Nephrology Medical Group
Sumter, South Carolina, 29150, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, 37404, United States
South Arlington Dialysis Center
Arlington, Texas, 76015, United States
Texas Renal Care
Greenville, Texas, 75402, United States
Med Center Dialysis
Houston, Texas, 77004, United States
Meyerland Dialysis
Houston, Texas, 77035, United States
Millenium Clinical Research, Inc.
Houston, Texas, 77054-11801, United States
Millennium Clinical Research, Inc.
Houston, Texas, 77054-11801, United States
Research Across America
Houston, Texas, 77054, United States
Southwest Houston Dialysis
Houston, Texas, 77071, United States
Southwest Houston Research, Ltd.
Houston, Texas, 77099, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
Private practice of Roberto Mangoo-Karim MD
McAllen, Texas, 78503, United States
Missouri City Dialysis
Missouri City, Texas, 77489, United States
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
San Antonio, Texas, 78229, United States
DaVita Dialysis Center-Floyd Curl Dialysis
San Antonio, Texas, 78240, United States
Clinical Research and Consulting Center, LLC
Fairfax, Virginia, 22030, United States
Peninsula Kidney Associates
Hampton, Virginia, 23666, United States
Internal Medicine Kidney and Hypertension Center
Norfolk, Virginia, 23502, United States
Consolidated Medical Plaza
Caguas, 00725, Puerto Rico
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 31, 2012
Primary Completion
February 11, 2014
Study Completion
February 11, 2014
Last Updated
September 10, 2018
Results First Posted
July 13, 2018
Record last verified: 2018-08