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Aranesp

Phase 3

Kidney Disease | Small molecule | Nephrology |Amgen Inc.|Last Updated: Jun 16, 2008

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
UNCONTROLLED
Total Trials2
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00116701Treatment for Subjects With Chronic Kidney Disease Receiving HaemodialysisPHASE3 COMPLETED 200May 1, 2005 -May 5, 2008 -
NCT00124098An Evaluation of Aranesp® in Subjects With Anaemic Chronic Kidney Disease (CKD)PHASE3 COMPLETED - - -Jun 16, 2008 -
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Study Endpoints
Primary Endpoints
Treatment period 1: Mean haemoglobin during the evaluation period (weeks 21-24)
Treatment period 2: Mean haemoglobin during evaluation period 2 (weeks 45-48)
Haemoglobin level
Secondary Endpoints
Treatment period 2: Change in Hb between Evaluation Period 1 and Evaluation Period 2
Treatment period 2: The proportion of subjects with a change in Hb between Evaluation Period 1 and Evaluation Period 2 within the inclusive range -1.0 to +1.5 g/dL
Treatment period 2: The proportion of subjects with a mean Hb > 11.0 g/dL during Evaluation Period 2
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Aranesp®DRUG -
Aranesp® (darbepoetin alfa)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: -at least 18 years old - Diagnosis of chronic kidney disease (CKD) and receiving dialysis for at least 3 months prior to screening - Baseline Hb level greater than or equal to 10.0 g/dL and less than or equal to 13.0 g/dL - Adequate iron stores (defined as serum ferritin greater ...

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