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

NCT01170078 | Completed Phase 1

• 1 other identifier: EPOE-10-08
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Chronic Renal Failure

Keywords

chronic renal failure requiring hemodialysis

Outcome Measures

Primary Outcomes (3)

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

  On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)

• Maximum serum epoetin concentration (Cmax)

  On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)

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

  If AUC0-48 cannot be calculated then AUC from time of dose administration to the time of the last measurable concentration (AUC0-t) will be used as the primary measure.

  On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)

Secondary Outcomes (6)

• Dose-adjusted Cmax

  On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)

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

  On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)

• Elimination rate Constant (λz)

  On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)

• Elimination halflife (t1/2)

  On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)

• Clearance (CL)

  On Day 1 and 2 of Pre-Treatment and Treatment Periods 1 and 2 predose (0 hour). On Day 3 of Pre-Treatment Period and Treatment Periods 1 and 2 (i.e., 3rd epoetin dose of the week) at predose (0 hour) and postdose (0.5, 1, 2, 4, 6, 8, 12, 24 and 48 hours)

Study Arms (2)

Arm A: Epoetin Hospira administered IV for three doses

EXPERIMENTAL

Drug: Epoetin Hospira

Arm B: Epogen administered IV for three doses

ACTIVE COMPARATOR

Drug: Epogen

Interventions

Epoetin Hospira DRUG

IV dose 3 times a week.

Arm A: Epoetin Hospira administered IV for three doses

Epogen DRUG

IV dose 3 times a week

Arm B: Epogen administered IV for three doses

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer: lead

Study Sites (20)

Unknown Facility

Downey, California, 90241, United States

Location

Unknown Facility

Tarzana, California, 91356-6123, United States

Location

Unknown Facility

Denver, Colorado, 80230, United States

Location

Unknown Facility

Middlebury, Connecticut, 06762, United States

Location

Unknown Facility

Lauderdale Lakes, Florida, 33313, United States

Location

Unknown Facility

Miami, Florida, 33150, United States

Location

Unknown Facility

Miami, Florida, 33173, United States

Location

Unknown Facility

Gurnee, Illinois, 60031, United States

Location

Unknown Facility

Wichita, Kansas, 67214, United States

Location

Unknown Facility

Detroit, Michigan, 48236, United States

Location

Unknown Facility

Pontiac, Michigan, 48341, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55404, United States

Location

Unknown Facility

Gulfport, Mississippi, 39501, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19106, United States

Location

Unknown Facility

Columbia, South Carolina, 29203, United States

Location

Unknown Facility

Knoxville, Tennessee, 37923, United States

Location

Unknown Facility

Houston, Texas, 77054, United States

Location

Unknown Facility

Houston, Texas, 77099, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Alexandria, Virginia, 22306, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 27, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 20, 2017

Record last verified: 2015-06

Locations

US (20)