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Clinical Trial Details

Trial ID: L0058
Source ID: NCT01170078
Associated Drug: Epoetin Hospira
Title: 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
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Renal Failure
Interventions: DRUG: Epoetin Hospira|DRUG: Epogen
Outcome Measures: Primary: 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: 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)|Volume of Distribution (Vd), 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)
Sponsor/Collaborators: Sponsor: Hospira, now a wholly owned subsidiary of Pfizer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 107
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2010-07
Completion Date: 2011-01
Results First Posted:
Last Update Posted: 2017-03-20
Locations: 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
URL: https://clinicaltrials.gov/show/NCT01170078