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Fosrenol

Phase 3

Chronic Kidney Disease, Stage 5 | Small molecule | Nephrology |Takeda Pharmaceutical Company Limited|Last Updated: Jun 11, 2021

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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment182
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00441545Head to Head Study Against Sevelamer HydrochloridePHASE3 COMPLETED 182Jan 5, 2007Jul 31, 2008Jun 11, 202144 United States, Germany +2
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Study Endpoints
Primary Endpoints
Change From Baseline in Serum Phosphorus Levels at 4 Weeks
4 weeks
Secondary Endpoints
Change From Baseline in Serum Calcium Levels at 4 Weeks
4 weeks
Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks
Baseline and 4 weeks
Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks
4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALFosrenol (Lanthanum carbonate)
2ACTIVE_COMPARATORSevelamer hydrochloride
Interventions
NameTypeDescription
Fosrenol (Lanthanum Carbonate)DRUGThe starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.
Sevelamer hydrochlorideDRUGThe starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * Adults with end stage renal disease who are receiving dialysis Exclusion Criteria: * Subjects with significant gastrointestinal disorders * Subjects who are pregnant or nursing * Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride...

Countries:United StatesGermanyPuerto RicoUnited Kingdom
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