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AEB071 b.i.d. / everolimus

Phase 2

Kidney Transplantation | Small molecule | Nephrology |Novartis AG|Last Updated: Feb 24, 2017

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 Enrollment175
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00820911Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant RecipientsPHASE2 COMPLETED 175 — — Sep 1, 2008Jul 1, 2012Feb 24, 201728 Argentina, Australia +15
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Study Endpoints
Primary Endpoints
renal function as measured by the glomerular filtration rate (GFR) using the modification of diet in renal disease (MDRD) formula
at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation
Secondary Endpoints
efficacy failure, defined as a composite efficacy endpoint of treated biopsy proven acute rejection, graft loss, death or loss to follow-up
at months 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months after transplantation
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
cyclosporine (reduced exposure) / everolimusACTIVE_COMPARATOR -
AEB071 300 mg b.i.d. / everolimusEXPERIMENTAL -
AEB071 200 mg b.i.d. / everolimusEXPERIMENTAL -
Interventions
NameTypeDescription
cyclosporine (reduced exposure) / everolimusDRUGtwice daily
AEB071 300 mg b.i.d. / everolimusDRUGtwice daily
AEB071 200 mg b.i.d. / everolimusDRUGtwice daily
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion criteria: * Patient has been maintained on study drug for 12 months in the core study Exclusion criteria: * Not applicable * Other protocol-defined inclusion/exclusion criteria may apply

Countries:ArgentinaAustraliaAustriaBelgiumBrazilColombiaCzechiaFranceGermanyItalyNetherlandsNorwaySingaporeSlovakiaSpainSwitzerlandTaiwan
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