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Epogen Amgen

Phase 3

Chronic Renal Failure | Monoclonal antibody | Nephrology |Pfizer, Inc.|Last Updated: Aug 9, 2018

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment320

FDA Designations

No designations recorded

Clinical trial landscape

Epogen Amgen · 1 trial · 2 indications

Phase 3 1
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 EpoetinChronic Renal Failure
COMPLETED320 Analytics
PHASE3COMPLETED
A 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 Epoetin
Chronic Renal FailureUnlock trial analytics

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 to 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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Frequently asked questions about Epogen Amgen

What is Epogen Amgen used for?

Epogen Amgen is a monoclonal antibody being studied for use in chronic renal failure, specifically in patients requiring hemodialysis and receiving epoetin maintenance treatment. It is being investigated for the management of anemia in this patient population.

Who makes Epogen Amgen?

Epogen Amgen is being developed by Pfizer, Inc., which trades under the ticker PFE. The drug is currently in Phase 3 clinical development for chronic renal failure.

What phase is Epogen Amgen in?

Epogen Amgen is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 study has been completed to evaluate its effects in patients with chronic renal failure.

What clinical trials is Epogen Amgen in?

Epogen Amgen has one completed Phase 3 clinical trial, NCT01473420, titled "A 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." The trial enrolled 320 participants in the United States.

Is Epogen Amgen the same as Epoetin Hospira?

Epogen Amgen is being compared to Epoetin Hospira in a clinical trial. The study is designed to compare the effects of subcutaneous Epoetin Hospira and Epoetin Alfa [Epogen] (Amgen) in patients with chronic renal failure requiring hemodialysis.