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Epoetin alfa RB

Phase 3

Nephrology | Small molecule | Nephrology |Amgen Inc.|Last Updated: Feb 26, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment420

FDA Designations

No designations recorded

Clinical trial landscape

Epoetin alfa RB · 1 trial · 1 indication

Phase 3 1
NCT00146224Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving HemodialysisNephrology
COMPLETED420 Analytics
PHASE3COMPLETED
Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis
NephrologyUnlock trial analytics

Study Endpoints

Primary Endpoints

Ratio of weekly dose at the evaluation period to the weekly dose at baseline
Entire Study
Change in Heloglobin level between the screening period and the evaluation period
Entire Study

Secondary Endpoints

Change from baseline Hb at each measurement timepoint
Entire Study
Maintaining Hemoglobin within range at each measurement timepoint
Entire Study
Average Epoetin alfa dose over evaluation period
evaluation period (weeks 21 - 28)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Epoetin alfa RBACTIVE_COMPARATOR -
Epoetin alfa DTEXPERIMENTAL -

Interventions

NameTypeDescription
Epoetin alfa RBDRUGReceive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
Epoetin alfa DTDRUGReceive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: - Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before randomization - Mean HB level between 10 and 13 g/dL (inclusive) (mean of 2 values drawn at least 3 days apart during the screening period) - Currently receiving a stable dose of Epoetin al...

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