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MMF + full-dose Neoral + corticosteroids

Phase 3

Kidney Transplantation | Small molecule | Nephrology |Novartis AG|Last Updated: Aug 22, 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
RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment696
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00099736Efficacy and Safety of FTY720 in Patients Who Receive a Kidney TransplantPHASE3 COMPLETED 696 — — May 7, 2003Sep 19, 2005Aug 22, 201742 United States
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Study Endpoints
Primary Endpoints
IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
permanent resumption of dialysis within 12 months post transplant
surgical removal of graft within 12 months post transplant
death within 12 months post transplant
withdrawal of consent, death, or lost to follow up within 12 months post transplant
Secondary Endpoints
FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at day 28, months 6 and 12
serum creatinine
cystatin C at months 3, 6, and 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids,EXPERIMENTAL -
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroidsEXPERIMENTAL -
MMF 2 g + full-dose Neoral (FDN) + corticosteroidsEXPERIMENTAL -
Interventions
NameTypeDescription
FTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroidsDRUGFTY720 5 mg + reduced-dose Neoral (RDN) + corticosteroids
FTY720 2.5 mg + full dose Neoral (FDN) + corticosteroidsDRUGFTY720 2.5 mg + full dose Neoral (FDN) + corticosteroids
MMF 2 g + full-dose Neoral (FDN) + corticosteroidsDRUGmycophenolate mofetil (MMF) + full-dose Neoral (FDN) + corticosteroids
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * First kidney transplantation * Male and female patients * Between 18 and 65 years old Exclusion Criteria: * Patients in need of multiple organ transplants

Countries:United States
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