DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Hospira, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Renal Failure

Intervention: Epoetin Hospira (Drug); Epogen (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Hospira, Inc.


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.

Clinical Details

Official title: A Phase 1 Study Comparing the Pharmacokinetics of Epoetin Hospira and Epoetin Alfa (Amgen) When Administered Intravenously in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Baseline-adjusted area under the serum epoetin concentration curve from the time of dose administration to 48 hours (AUC0-48)

Maximum serum epoetin concentration (Cmax)

AUC from time of dose administration to the time of the last measurable concentration (AUC0-t)

Secondary outcome:

Dose-adjusted Cmax

AUC from time of dose administration to the time of the last measurable concentration (AUC0-t)

Elimination rate Constant (λz)

Elimination halflife (t1/2)

Clearance (CL)

Volume of Distribution (Vd)

Detailed description: This is a multicenter, active-controlled, cross-over, evaluator-blind, Phase I study in patients with chronic renal failure requiring hemodialysis. The study comprises a 4-week Screening Period, a 1-week Pre-Treatment Period, a 1-week Treatment Period 1, a 1-week Treatment Period 2 and a Follow-up visit at Week 7. Subject eligibility will be determined during the 4-week Screening Period. All subjects must be optimally titrated and stable to qualify for entry into Pre-Treatment Period. During the 1-week Pre-treatment period the patients will continue on the same stable dose as they received during the Screening Period. Blood samples will be collected during the Pre-Treatment Period to assess pharmacokinetics of Epogen. Eligible subjects will be randomized at Day 1 of Treatment Period 1 to receive either Epoetin Hospira or Epogen (Amgen) by intravenous (IV) bolus injections administered three times a week for 1 week. Subjects will then be switched to receive the alternate study drug for three times a week for 1 week in Treatment Period 2. Blood samples will be collected during Treatment periods 1 and 2 to assess pharmacokinetics of Epoetin Hospira and Epogen. Primary endpoint, i. e. pharmacokinetics concentrations, will be evaluator blinded. After completing Treatment Period 2, all subjects will receive standard of care treatment and will undergo a Follow-up Visit at Week 7 (i. e., 28 days after Treatment Period 2).


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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


- 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.

Locations and Contacts

Downey, California 90241, United States

Tarzana, California 91356-6123, United States

Denver, Colorado 80230, United States

Middlebury, Connecticut 06762, United States

Lauderdale Lakes, Florida 33313, United States

Miami, Florida 33150, United States

Miami, Florida 33173, United States

Gurnee, Illinois 60031, United States

Wichita, Kansas 67214, United States

Detroit, Michigan 48236, United States

Pontiac, Michigan 48341, United States

Minneapolis, Minnesota 55404, United States

Gulfport, Mississippi 39501, United States

Philadelphia, Pennsylvania 19106, United States

Columbia, South Carolina 29203, United States

Knoxville, Tennessee 37923, United States

Houston, Texas 77054, United States

Houston, Texas 77099, United States

San Antonio, Texas 78229, United States

Alexandria, Virginia 22306, United States

Additional Information

Starting date: July 2010
Last updated: June 12, 2015

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017