A Study Comparing the Effects of Epoetin Hospira and Epoetin Alpha (Amgen) When Administered IV in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment
This study will assess the pharmacokinetics (PK) of epoetin from Epoetin Hospira and Epogen in patients with renal failure receiving hemodialysis treatment.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
- Area under the curve (AUC) [ Time Frame: PK samples will be collected during the Pre-treatment period, Treatment Period ! and Treatment Period 2 and for Dose 3 of Pre-treatment period, Treatment period 1 and Treatment Period 2 at various timepoints over 48 hours following dose administration ] [ Designated as safety issue: No ]
|Study Start Date:||July 2010|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|Experimental: Arm A: Epoetin Hospira administered IV for three doses||
Drug: Epoetin Hospira
IV dose 3 times a week.
|Active Comparator: Arm B: Epogen administered IV for three doses||
IV dose 3 times a week
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).
|United States, California|
|Tarzana, California, United States, 91356-6123|
|Whittier, California, United States, 90603|
|United States, Colorado|
|Denver, Colorado, United States, 80230|
|United States, Connecticut|
|Middlebury, Connecticut, United States, 06762|
|United States, Florida|
|Miami, Florida, United States, 33150|
|Miami, Florida, United States, 33173|
|Plantation, Florida, United States, 33324|
|United States, Illinois|
|Gurnee, Illinois, United States, 60031|
|United States, Kansas|
|Wichita, Kansas, United States, 67214|
|United States, Maryland|
|Ft. Washington, Maryland, United States, 20744|
|United States, Michigan|
|Detroit, Michigan, United States, 48236|
|Pontiac, Michigan, United States, 48341|
|United States, Minnesota|
|Minneapolis, Minnesota, United States, 55404|
|United States, Mississippi|
|Gulfport, Mississippi, United States, 39501|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19106|
|United States, South Carolina|
|Columbia, South Carolina, United States, 29203|
|United States, Tennessee|
|Knoxville, Tennessee, United States, 37921|
|United States, Texas|
|Houston, Texas, United States, 77054|
|Houston, Texas, United States, 77071|
|San Antonio, Texas, United States, 78229|