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

Phase 3

Completed

Conditions: Chronic Kidney Disease
Chronic Renal Failure

Interventions: Biological: Epogen (Amgen)
Biological: Epoetin Hospira

Registration Number: NCT01473407

Lead Sponsor: Pfizer

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 612

Inclusion Criteria

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

Exclusion Criteria

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
Relative or absolute iron deficiency prior to randomization
Platelet count below 100 x 10^9/L
Clinically relevant increase of CRP (>10 mg/dL) for at least 2 weeks
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 the study participation
History of any of the following:
- Detectable anti- rhEPO antibodies
- Clinically relevant malnutrition
- Confirmed aluminum intoxication
- Myelodysplastic syndrome
- Known bone marrow fibrosis (osteitis fibrosa cystica)
- Known seizure disorder
- Liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites)
A female patient who is pregnant, lactating or planning a pregnancy during the study
History of drug abuse or alcohol abuse within 2 years prior to randomization as determined by the Investigator
Current participation or participation in a drug or other investigational research study within 30 days prior to randomization
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
Donated or lost >475 mL (i.e., 1 pint) blood volume (including plasmapheresis) or had a transfusion of any blood product within 3 months prior to randomization
A patient who in the Investigator's opinion, has any clinically significant abnormal laboratory evaluations, including liver function taken at Screening Visit
Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epogen (Amgen)	Epogen (Amgen)	Epogen (Amgen)
Epoetin Hospira	Epoetin Hospira	Epoetin Hospira

Primary Outcome Measures

Name	Time	Method
Mean Weekly Dosage of Study Medication From Week 21 to Week 24	Week 21 up to Week 24
Mean Weekly Hemoglobin Level From Week 21 to Week 24	Week 21 up to Week 24

Secondary Outcome Measures

Name	Time	Method
Total Dose of Study Medication Administered	Week 1 up to Week 24
Percentage of Participants Who Required Temporary Dose Changes of Study Medication	Week 1 up to Week 24
Number of Participants With Change in Mean Dose of Study Medication Based on Hemoglobin Level	Week 1 up to Week 24	In this outcome measure number of participants with change (increase and decrease) in mean dose of Epoetin Hospira and Epogen were categorized and reported according to their mean hemoglobin levels. Hemoglobin levels were divided in following classes: \>11.0 g/dL, from 9.0 to 11.0 g/dL and \<9.0 g/dL
Mean Weekly Dosage of Study Medication Through 24 Weeks	Week 1 up to Week 24
Percentage of Participants Who Received Blood Transfusions	Week 1 up to Week 24
Mean Weekly Hemoglobin Level Through 24 Weeks	Week 1 up to Week 24
Percentage of Participants With Any Transient Change of Hemoglobin Level Greater Than (>) 1 Gram Per Deciliter (g/dL)	Week 1 up to Week 24
Percentage of Participants With Any Transient Change of Hemoglobin Greater Than (>) 2.0 Gram Per Deciliter (g/dL) in Hemoglobin Level	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 had hemoglobin level within the target range of 9 to 11 g/dL for the specified weeks were reported.
Percentage of Participants With Mean Weekly Hemoglobin Level Outside the Target Range	Week 12, 24	Percentage of participants who had hemoglobin level outside the target range of 9 to 11 g/dL for the specified weeks were reported.
Percentage of Participants Who Required Permanent Dose Changes of Study Medication	Week 1 up to Week 24

Trial Locations

Locations (83): Clinical Research and Consulting Center, LLC
🇺🇸
Fairfax, Virginia, United States
Consolidated Medical Plaza
🇵🇷
Caguas, Puerto Rico
Internal Medicine Kidney and Hypertension Center
🇺🇸
Norfolk, Virginia, United States
Peninsula Kidney Associates
🇺🇸
Hampton, Virginia, United States
San Marcus Research Clinic, Inc
🇺🇸
Miami, Florida, United States
Nephrology Associates of South Miami
🇺🇸
Miami, Florida, United States
Kidney Specialists of Southern Nevada
🇺🇸
Las Vegas, Nevada, United States
DaVita Dialysis Centers
🇺🇸
Clinton Township, Michigan, United States
Montgomery Kidney Specialists
🇺🇸
Montgomery, Alabama, United States
Southwest Clinical Research Institute, LLC
🇺🇸
Tempe, Arizona, United States
Lakhi M. Sakhrani, MD A Medical Coporation
🇺🇸
Alhambra, California, United States
North America Research Institute
🇺🇸
Azusa, California, United States
DaVita Dialysis Center-Bakersfield Dialysis Center
🇺🇸
Bakersfield, California, United States
Ong, Rubin, Shahmir A Medical Corp DBA: Solano Kidney Care
🇺🇸
Fairfield, California, United States
A Medical Corporation
🇺🇸
Glendale, California, United States
Renal Consultants Medical Group
🇺🇸
Granada Hills, California, United States
La Puente Dialysis Center
🇺🇸
La Puente, California, United States
Advanced Medical Research, LLC
🇺🇸
Lakewood, California, United States
DaVita Bixby Knolls Dialysis
🇺🇸
Long Beach, California, United States
Bayview Nephrology, Inc
🇺🇸
Erie, Pennsylvania, United States
Academic Medical Research Institute
🇺🇸
Los Angeles, California, United States
Desert Nephrology Medical Group
🇺🇸
Sumter, South Carolina, United States
La Jolla Clinical Research, Inc.
🇺🇸
National City, California, United States
Valley Renal Medical Group
🇺🇸
Northridge, California, United States
Ontario Dialysis Inc
🇺🇸
Ontario, California, United States
Nephrology Educational Services and Research, Inc
🇺🇸
Tarzana, California, United States
Discovery medical Research Group, Inc.
🇺🇸
Porterville, California, United States
Queen Dialysis Center
🇺🇸
West Covina, California, United States
American Institute of Research
🇺🇸
Whittier, California, United States
Mark C. Lee, Inc. Santa Fe Springs Dialysis
🇺🇸
Whittier, California, United States
North Valley Nephrology
🇺🇸
Yuba City, California, United States
Nephrology and Hypertension Associates
🇺🇸
Middlebury, Connecticut, United States
South Florida Nephrology, Inc.
🇺🇸
Coral Springs, Florida, United States
ARA Naples South Dialysis Center
🇺🇸
Naples, Florida, United States
ARA- Naples Dialysis Center, LLC
🇺🇸
Naples, Florida, United States
Innovative Medical Research of South Florida, Inc.
🇺🇸
North Miami Beah, Florida, United States
Discovery Medical Research Group, Inc.
🇺🇸
Ocala, Florida, United States
Renal Physicians of Georgia, PC
🇺🇸
Dublin, Georgia, United States
Boise Kidney & Hypertension Institute, PLLC
🇺🇸
Meridian, Idaho, United States
Research by Design, LLC
🇺🇸
Evergreen Park, Illinois, United States
North Suburban Nephrology, LLC
🇺🇸
Gurnee, Illinois, United States
Northwest Louisiana Nephrology
🇺🇸
Shreveport, Louisiana, United States
Nephrology Specialists, PC
🇺🇸
Merrillville, Indiana, United States
Internal Medicine Specialists
🇺🇸
New Orleans, Louisiana, United States
Westbank Nephrology Associates
🇺🇸
Marrero, Louisiana, United States
St. Clair Specialty Physicians, P.C.
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Detroit, Michigan, United States
South Mississippi Medical Research, PLLC
🇺🇸
Gulfport, Mississippi, United States
Chromalloy American Kidney Center
🇺🇸
Saint Louis, Missouri, United States
Brookdale Physician Dialysis Associates
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Brooklyn, New York, United States
Lower Manhattan Dialysis Center
🇺🇸
New York, New York, United States
Mountain Kidney and Hypertension Associates, PA
🇺🇸
Asheville, North Carolina, United States
East Carolina University, ECU School of Medicine, Department of Internal Medicine
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Greenville, North Carolina, United States
Eastern Nephrology Associates, PLLC
🇺🇸
New Bern, North Carolina, United States
Cincinnati VA Medical Center
🇺🇸
Cincinnati, Ohio, United States
HNC Dialysis Ltd.
🇺🇸
Columbus, Ohio, United States
DaVita-Erie Dialysis Center
🇺🇸
Erie, Pennsylvania, United States
UPMC Hamot Clinical Trials Department
🇺🇸
Erie, Pennsylvania, United States
Franklin Dialysis Center
🇺🇸
Philadelphia, Pennsylvania, United States
Delaware Valley Nephrology and Hypertension Associates, PC
🇺🇸
Philadelphia, Pennsylvania, United States
Nephrology and Internal Medicine of Anderson
🇺🇸
Anderson, South Carolina, United States
Columbia Nephrology Associates, P.A.
🇺🇸
Columbia, South Carolina, United States
Palmetto Nephrology, PA
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Orangeburg, South Carolina, United States
South Carolina Nephrology and Hypertension Center, Inc.
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Orangeburg, South Carolina, United States
Southeast Renal Research Institute
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Chattanooga, Tennessee, United States
South Arlington Dialysis Center
🇺🇸
Arlington, Texas, United States
Texas Renal Care
🇺🇸
Greenville, Texas, United States
Med Center Dialysis
🇺🇸
Houston, Texas, United States
Meyerland Dialysis
🇺🇸
Houston, Texas, United States
Millenium Clinical Research, Inc.
🇺🇸
Houston, Texas, United States
Millennium Clinical Research, Inc.
🇺🇸
Houston, Texas, United States
Research Across America
🇺🇸
Houston, Texas, United States
Southwest Houston Dialysis
🇺🇸
Houston, Texas, United States
Texas Tech University Health Sciences Center
🇺🇸
Lubbock, Texas, United States
Southwest Houston Research, Ltd.
🇺🇸
Houston, Texas, United States
Private practice of Roberto Mangoo-Karim MD
🇺🇸
McAllen, Texas, United States
Missouri City Dialysis
🇺🇸
Missouri City, Texas, United States
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
🇺🇸
San Antonio, Texas, United States
DaVita Dialysis Center-Floyd Curl Dialysis
🇺🇸
San Antonio, Texas, United States
South Florida Research Institute
🇺🇸
Lauderdale Lakes, Florida, United States
Columbia Nephrology Associates, PA
🇺🇸
Columbia, South Carolina, United States
Central Florida Kidney Centers
🇺🇸
Orlando, Florida, United States
Brookview Hills Research Associates, LLC
🇺🇸
Winston-Salem, North Carolina, United States
Hypertension & Nephrology Associates
🇺🇸
Eatontown, New Jersey, United States