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1278863A

Phase 2

Kidney Disease | Small molecule | Nephrology |GSK plc|Last Updated: Nov 11, 2013

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
RandomizedPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment107
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01047397Repeat Dose Safety and Efficacy Study for Compound to Treat AnemiaPHASE2 COMPLETED 107Mar 1, 2010Feb 1, 2011Nov 11, 201337 Australia, India +2
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Study Endpoints
Primary Endpoints
Rate of response for increase from baseline of hemoglobin levels
Pre-dose, Day 1, Day 15, Day 22, Follow-up
Adverse Events reporting
throughout study
Safety Labs (Chemistry)
Screening, Day 1, 4, 8, 15, 22, 29, 36, 57
Safety Labs (Hematology)
Screening, Day 1, 4, 8, 15, 22, 29, 36, 57
Safety Labs (Urinalysis)
Screening, Day 1, 4, 8, 15, 22, 29, 36, 57
Vital Signs (blood pressure and heart rate)
Screening, Day 1, 4, 8, 15, 22, 29, 36, 57
ECG
Screening, Day 1, 4, 8, 15, 22, 29, 36, 57
Secondary Endpoints
AUC (0-∞), Cmax, tmax, t½
Day 1, 15, 22
Actual values and change from baseline for erythropoietin, absolute and percent reticulocytes, hematocrit, and total RBCs
Day 1, 15, 22, Folllow-up
Actual values and change from baseline for VEGF, hepcidin, TIBC
Day 1, 15, 22, Follow-up
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALActive Drug
Group 2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
1278863ADRUG25mg, 50mg, 100mg
PlaceboDRUGmatching placebo
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: 1. Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent. 2. A male or female is eligible to enroll and participate in this study if he/she: 1. (Part 1) has Moderate to Severe Renal Impairment (equivalent to NKF KDOQI Stage 3 or...

Countries:AustraliaIndiaNew ZealandRussia
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