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Mycophenolate

Phase 3

Renal Transplant | Small molecule | Nephrology |Novartis AG|Last Updated: Nov 18, 2016

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-BlindUNCONTROLLED
Total Trials4
Total Enrollment949
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00149903Study of Enteric-coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult de Novo Renal Transplant PatientsPHASE3 COMPLETED 300 — — Jan 1, 2005 -Nov 18, 20161 China
NCT00149916Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A0107PHASE3 COMPLETED 139 — — Apr 1, 2000 -Nov 2, 2011 - —
NCT00149864Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302PHASE3 COMPLETED 264 — — Feb 1, 2000Dec 1, 2003Feb 2, 2011 - —
NCT00149929Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301PHASE3 COMPLETED 246 — — Dec 1, 1999Apr 1, 2003Feb 2, 2011 - —
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Study Endpoints
Primary Endpoints
Efficacy of EC-MPS compared to MMF in Chinese patients as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant recipients.
To assess gastro-intestinal tolerability
To assess the incidence and severity of GI adverse events (AEs) and neutropenia in the first 3 months of treatment in maintenance renal transplant patients.
Incidence of biopsy proven acute rejection, graft loss, or death in the first six months of treatment.
Secondary Endpoints
Incidence of biopsy proven acute rejection within six months of treatment in de novo renal transplant recipients
Other variables of efficacy: chronic rejection, graft loss, death.
Safety of EC-MPS as measured by incidence of adverse events and serious adverse events.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Mycophenolate sodium (enteric coated)EXPERIMENTAL -
Interventions
NameTypeDescription
Mycophenolate sodium (enteric coated)DRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Recipients of first, cadaveric (with donor written consent form) or living related non-HLA identical donor kidney transplant, * treated with cyclosporine and corticosteroids as primary immunosuppression. Exclusion Criteria: * Second or subsequent kidney transplant or multi-o...

Countries:China
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