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Osvaren Granules

Phase 2

Hyperphosphatemia | Small molecule | Nephrology |Fresenius Medical Care AG|Last Updated: Jun 10, 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 Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02027662Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® GranulesPHASE2 COMPLETED 61 — — Jan 1, 2014Jun 1, 2015Jun 10, 201511 Germany
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Study Endpoints
Primary Endpoints
Non-inferiority of phosphate control by granules versus tablets. Serum phosphate levels will be measured for the primary outcome.
After 4 weeks of treatment time
Secondary Endpoints
Number of patients reaching serum phosphate levels < 1.76 mmol/L. this study to evaluate the safety profile of OsvaRen® granules. in comparison to OsvaRen® tablets. Especially serum calcium, magnesium, and PTH are of interest.
Between the first and last visit under each treatment i.e. 4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelFACTORIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Osvaren GranulesEXPERIMENTALOsvaren Granules
Osvaren film-coated tabletsACTIVE_COMPARATOROsvaren film-coated tablets
Interventions
NameTypeDescription
Osvaren GranulesDRUG -
Osvaren film-coated tabletsDRUG -
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Signed written informed consent form is obtained prior to starting the screening visit * Male and female patients 18-80 years of age with dialysis dependent renal failure (CKD 5D) * Patients have been on 3x/week in-centre renal replacement therapy for at least 2 months on eith...

Countries:Germany
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