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Epoetin

Phase 3

Anemia | Small molecule | Hematology |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment182

FDA Designations

No designations recorded

Clinical trial landscape

Epoetin · 1 trial · 1 indication

Phase 3 1
NCT00077597A Study of Mircera for the Treatment of Anemia in Dialysis PatientsAnemia
COMPLETED182 Analytics
PHASE3COMPLETED
A Study of Mircera for the Treatment of Anemia in Dialysis Patients
AnemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Hemoglobin response rate
Weeks 1-24

Secondary Endpoints

Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n
Throughout study
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
epoetinDRUG3 times a week iv, as prescribed.
methoxy polyethylene glycol-epoetin beta [Mircera]DRUG0.4 micrograms/kg iv (starting dose) once every 2 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites59

Inclusion Criteria: * adult patients \>=18 years of age; * chronic renal anemia; * dialysis therapy for at least 2 weeks before screening. Exclusion Criteria: * women who are pregnant, breastfeeding or using unreliable birth control methods; * administration of any investigational drug within 4 w...

Countries:United StatesBrazilCanadaCzechiaGreeceNorwayPolandRussiaSouth AfricaSpainSwedenSwitzerlandThailand
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