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Sevelamer

Phase 3

Peritoneal Dialysis | Small molecule | Nephrology |Sanofi|Last Updated: Mar 18, 2015

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment138
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00196755Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal DialysisPHASE3 COMPLETED 138Dec 1, 2004Apr 1, 2006Mar 18, 201517 Belgium, Denmark +5
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Study Endpoints
Primary Endpoints
Compare the effects of sevelamer dosed three times per day (TID) and calcium acetate dosed TID on serum phosphorus.
12 weeks
Secondary Endpoints
Serum calcium- phosphorus (CaxPO4) product
12 weeks
Serum lipids - total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides
12 weeks
Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Sevelamer Hydrochloride (Renagel®)EXPERIMENTAL -
Calcium acetate (PhosLo® )ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Sevelamer Hydrochloride (Renagel®)DRUGSevelamer hydrochloride three times per day with each meal
Calcium acetate (PhosLo® )DRUGCalcium acetate three times per day with each meal
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Willing and able to sign an informed consent form. * Men or women aged 18 years of age or older. * A diagnosis of Chronic Kidney Disease (CKD) and receiving peritoneal dialysis (Continuous cyclical peritoneal dialysis (CAPD), Automated peritoneal dialysis (APD) or Continuous c...

Countries:BelgiumDenmarkFranceItalyNetherlandsSpainUnited Kingdom
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