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Rapamune

Phase 3

Kidney Disease | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: Mar 10, 2010

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment470
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00248313Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking SirolimusPHASE3 COMPLETED 470Jul 1, 2000Oct 1, 2007Mar 10, 2010 -
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Study Endpoints
Primary Endpoints
Kidney Function at 12 months after transplantation.
Secondary Endpoints
Kidney function at 6 months; incidence of side effects and rejection at 6 and 12 months.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
Rapamune®DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Age: = to ≥ 18 years. * End-stage renal disease, with patients scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related donor. * Patients with second and subsequent transplants must have maintai...

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