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.
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Inclusion Criteria:
1. Patient is able to provide written informed consent after risks and benefits of the
study have been explained prior to any study related activities
2. 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
3. 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
4. Patients with adequate iron stores, defined as plasma ferritin > 100 μg/L and TSAT
>20%, prior to randomization
5. Male or female patients aged 18 to 80 years (both inclusive)
6. 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
Exclusion Criteria:
1. Maintenance epoetin dosage >600 U/kg per week (1-3 times per week)
2. Treatment with long-acting epoetin analogues such as Aranesp ® within 12 weeks prior
to randomization
3. 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)
4. 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
5. Known, clinically manifested deficiency of folic acid and/or vitamin B12
(irrespective of whether currently treated or not)
6. 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
7. Contraindication for the test drug or have been previously treated with Epoetin
Hospira
8. Relative or absolute iron deficiency prior to randomization into the Maintenance
Period
9. Platelet count below 100 x 10^9/L
10. Clinically relevant increase of CRP (>10 mg/dL) for at least 2 weeks
11. 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
12. 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)
13. A female patient who is pregnant, lactating or planning a pregnancy during the study
14. History of drug abuse or alcohol abuse within 2 years prior to randomization as
determined by the Investigator
15. Current participation or participation in a drug or other investigational research
study within 30 days prior to randomization
16. 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
17. 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
18. A patient who in the Investigator's opinion, has any clinically significant abnormal
laboratory evaluations, including liver function taken at Screening Visit
19. Positive laboratory test for human immunodeficiency virus (HIV) or hepatitis B
surface antigen (HBsAg)
Azusa, California 91702, United States
Bakersfield, California 93309, United States
Granada Hills, California 91344, United States
Long Beach, California 90813, United States
Los Angeles, California 90022, United States
Modesto, California 95350, United States
Northridge, California 91324, United States
Paramount, California 90723, United States
Sacramento, California 95825, United States
San Leandro, California 94578, United States
Whittier, California 90603, United States
Arvada, Colorado 80002, United States
Westminister, Colorado 80031, United States
Jupiter, Florida 33458, United States
Pembroke Pines, Florida 33028, United States
Albany, Georgia 31701, United States
Augusta, Georgia 30909, United States
Dublin, Georgia 31021, United States
Evergreen Park, Illinois 60805, United States
Witchita, Kansas 67214, United States
Lafayette, Louisiana 70506, United States
Marrero, Louisiana 70072, United States
Shreveport, Louisiana 71101, United States
Kalamazoo, Michigan 49007, United States
Kansas City, Missouri 64111, United States
Kansas City, Missouri 64131, United States
Saint Louis, Missouri 63136, United States
New Hyde Park, New Jersey 11040, United States
North Brunswick, New Jersey 08902, United States
Voorhees, New Jersey 08043, United States
College Point, New York 11356, United States
Flushing, New York 11355, United States
New York, New York 10010, United States
Raleigh, North Carolina 27609, United States
Cincinnati, Ohio 45267-0585, United States
Toledo, Ohio 43606, United States
Meadville, Pennsylvania 16355, United States
Columbia, South Carolina 29203, United States
Orangeburg, South Carolina 29118, United States
Knoxville, Tennessee 37923, United States
Austin, Texas 78758, United States
Dallas, Texas 75216, United States
Grand Prairie, Texas 75051, United States
Houston, Texas 77054, United States
Houston, Texas 77099, United States
Lufkin, Texas 75904, United States
San Antonio, Texas 78224, United States
Mechanicsville, Virginia 23116, United States