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) 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
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 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 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
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 3 months 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
(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
7. Contraindication for the test drug or have been previously treated with Epoetin
Hospira
8. Relative or absolute iron deficiency prior to randomization
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)