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FTY 720

Phase 3

Kidney Transplantation | Small molecule | Nephrology |Novartis AG|Last Updated: Jun 7, 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-BlindUNCONTROLLED
Total Trials3
Total Enrollment395
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00099801Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney TransplantPHASE3 COMPLETED - — — Jan 1, 2005Mar 1, 2006Jun 7, 2017 - —
NCT00098735Efficacy and Safety of FTY720 in Patients Who Receive a Kidney TransplantationPHASE3 COMPLETED 140 — — Apr 1, 2004 -Nov 18, 2016 - —
NCT00099749Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney TransplantPHASE2 COMPLETED 255 — — Nov 1, 2003 -Feb 23, 20175 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 6 months post transplant
Permanent resumption of dialysis within 6 months post transplant
Surgical removal of graft within 6 months post transplant
Death within 6 months post transplant
Withdrawal of consent, death, or lost to follow up within 6 months post transplant
Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.
Secondary 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
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
FTY720DRUG -
FTY 720DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patients undergoing their first kidney transplant * Male or female age 18 to 65 years Exclusion Criteria: * Patients in need of second kidney transplant or multi-organ transplants.

Countries:United States
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