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Epogen

Phase 3

Chronic Kidney Disease | Monoclonal antibody | Nephrology |Pfizer, Inc.|Last Updated: Sep 10, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment612
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01473407A Phase 3 Study Comparing the Effects of Intravenous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With EpoetinPHASE3 COMPLETED 612Jan 31, 2012Feb 11, 2014Sep 10, 201885 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Mean Weekly Hemoglobin Level From Week 21 to Week 24
Week 21 up to Week 24
Mean Weekly Dosage of Study Medication From Week 21 to Week 24
Week 21 up to Week 24
Secondary Endpoints
Mean Weekly Hemoglobin Level Through 24 Weeks
Week 1 up to Week 24
Mean Weekly Dosage of Study Medication Through 24 Weeks
Week 1 up to Week 24
Total Dose of Study Medication Administered
Week 1 up to Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Epoetin HospiraEXPERIMENTALEpoetin Hospira
Epogen (Amgen)ACTIVE_COMPARATOREpogen (Amgen)
Interventions
NameTypeDescription
Epoetin HospiraBIOLOGICALVariable dose
Epogen (Amgen)BIOLOGICALVariable dose
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites85

Inclusion Criteria: 1. Patient is able to provide written informed consent after risks and benefits of the study have been explained prior to any study related activities 2. Hemodialysis patients with chronic renal failure and renal anemia currently on stable Epogen (Amgen) treatment for at least 4...

Countries:United StatesPuerto Rico
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