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