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Epogen Amgen

Phase 3

Chronic Renal Failure | Monoclonal antibody | Nephrology |Pfizer, Inc.|Last Updated: Aug 9, 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 Enrollment320
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01473420A Phase 3 Study Comparing the Effects of Subcutaneous 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 320 — — Jan 17, 2012Feb 28, 2014Aug 9, 201873 United States
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Study Endpoints
Primary Endpoints
Mean Weekly Hemoglobin Level From Week 30 to Week 34: Maintenance Period
Week 30 up to Week 34
Mean Weekly Dosage of Study Medication From Week 30 to Week 34: Maintenance Period
Week 30 up to Week 34
Secondary Endpoints
Mean Weekly Hemoglobin Level From Week 19 to Week 34: Maintenance Period
Week 19 up to Week 34
Mean Weekly Dosage of Study Medication From Week 19 to Week 34: Maintenance Period
Week 19 up to Week 34
Total Dose of Study Medication Administered: Maintenance Period
Week 19 up to Week 34
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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 AmgenBIOLOGICALVariable dose
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites73

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) dose administered IV or ...

Countries:United States
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