Overview

A Study Comparing the Effects of Epoetin Hospira and Epogen/Epoetin Alfa (Amgen) When Administered IV in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment

Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
0
Participant gender:
All
Summary
This study assessed the comparability of the pharmacokinetics (PK) of epoetin following intravenous administration of Hospira Epoetin and Epogen/Epoetin Alfa (Amgen) in patients with chronic renal failure receiving hemodialysis treatment.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospira, Inc.
Hospira, now a wholly owned subsidiary of Pfizer
Treatments:
Epoetin Alfa
Criteria
Inclusion Criteria:

- Able to provide written informed consent after risks and benefits of the study have
been explained prior to any study related activities.

- Males and females between 18 and 75 years of age (both inclusive).

- Hemodialysis patients with chronic renal failure and anemia currently on stable
epoetin treatment for at least 4 weeks prior to the Day 1 of Pre-treatment where
during this period:

- Epogen/Epoetin Alfa (Amgen) dose has been administered IV, 3 times a week and
where each dose is <= 200 International Units(IU)/KG.

- Hb levels were maintained within the 10-12 g/dL, with no more than a 0.5 g/dL
change from the mean over this period.

- No dose change during the last 4 weeks prior to Day 1 of pre-treatment period.

- Subjects on stable, adequate dialysis for at least 12 weeks prior to randomization,
defined as no clinically relevant changes of dialysis regimen and/or dialyzer.

- Subjects with adequate iron stores, defined as serum ferritin >= 100 µg/L and
transferrin saturation (TSAT) >20% prior to randomization.

- If female, subject must be postmenopausal for at lest 1 year prior to randomization,
surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy),
or practicing at least one of the following forms 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 subject is currently using a hormonal
contraceptive, she should also use a barrier method during this study and for 1 month after
last dose of Study Medication (Dosing Day 3 of Treatment Period 2).

Exclusion Criteria:

- A subject with any active, uncontrolled systemic disease 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 (including
demyelinating diseases such as multiple sclerosis).

- History of drug abuse or alcohol abuse within 2 years prior to randomization as
determined by the Investigator or a positive serum or saliva drug screen during the
Screening Period or on Day 1 of each Treatment Period.

- Significant drug sensitivity or a significant allergic reaction to any drug, as well
as known hypersensitivity or idiosyncratic reaction to epoetin (or it's excipients,
including albumin) or any other related drugs.

- A subject who in the Investigator's opinion, has any clinically significant abnormal
laboratory evaluations, including Human Immunodeficiency Virus (HIV), Hepatitis B
virus surface antigen (HBsAg) and liver function taken at Screening Visit.

- Current treatment with long-acting epoetin analogues such as Aranesp.

- The following within 6 months prior to randomization: unstable congestive heart
failure (New York Heart Association [NYHA] class III or IV), cerebrovascular accident,
myocardial infarction, coronary angioplasty or by-pass surgery.

- Uncontrolled hypertension in Investigator's opinion within 4 weeks prior to
randomization.

- A subject who has received a recent (within last 6 months) live or attenuated
vaccination (except flu vaccination).

- A female subject who is pregnant, nursing, or planning a pregnancy during the study.

- Donated or lost >= 457 ml (i.e., 1 pint) blood volume (including plasmapheresis) or
had a transfusion of any blood product within 3 months prior to randomization.

- Known clinically manifested untreated deficiency of folic acid and/or vitamin B12.

- 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 trial, communicate
effectively with study personnel, or is considered by the Investigator, for any
reason, to be an unsuitable candidate for the study.

- Known positive test for anti-epoetin antibodies.