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SBR759A

Phase 3

Hyperphosphatemia | Small molecule | Nephrology |Novartis AG|Last Updated: Dec 19, 2020

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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment115
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01069692Placebo Versus SBR759 in Lowering Phosphate in Dialysis PatientsPHASE3 COMPLETED 115 — — Feb 1, 2010 -Dec 19, 20209 Belgium, Italy
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Study Endpoints
Primary Endpoints
Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment
6 weeks
Secondary Endpoints
Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment
6 weeks
Evaluate dose-dependent efficacy of SBR759
6 weeks
Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo
6 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1PLACEBO_COMPARATORPlacebo
Arm 3EXPERIMENTAL -
Arm 2EXPERIMENTAL -
arm 4EXPERIMENTALSBR759A
arm 5EXPERIMENTAL -
Interventions
NameTypeDescription
SBR759ADRUGSBR759A 6g daily
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion criteria: 1. Men or women of at least 18 years of age 2. Stable maintenance of hemodialysis 3 times per week for 3 months or greater 3. Controlled serum phosphate if under phosphate-binder therapy 4. Patient must either be on a stable phosphate binder dose and are willing to stop their ph...

Countries:BelgiumItaly
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