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darbepoetin alfa SF

Phase 3

Kidney Disease | Small molecule | Nephrology |Amgen Inc.|Last Updated: May 24, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment1,100

FDA Designations

No designations recorded

Clinical trial landscape

darbepoetin alfa SF · 1 trial · 2 indications

Phase 3 1
NCT00093977Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney DiseaseKidney Disease
COMPLETED1,100 Analytics
PHASE3COMPLETED
Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease
Kidney DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine whether darbepoetin alfa manufactured by a roler bottle technology (darbepoetin alfa RB) and darbepoetin alfa manufactured by a serum free process (darbepoetin alfa SF) have a comparable safety profile
Entire Study

Secondary Endpoints

To characterize laboratory parameters in subjects with CKD
Entire Study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
darbepoetin alfa SFEXPERIMENTAL -

Interventions

NameTypeDescription
darbepoetin alfa SFDRUGFrequency of dosing depends on frequency at randomization: rHuEPO QW = darbepoetin alfa SF Q2W (dosing conversion table in protocol) rHuEPO biw or tiw = darbepoetin alfa SF QW (dosing conversion table in protocol) darbepoetin alfa RB = darbepoetin alfa SF at same dose and frequency PFS 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 200 or 300 mcg; Hb maintained between 11.0 - 13.0 g/dL
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis * Anemic * Currently on erythropoietic therapy * Controlled hypertension * Clinically stable

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