Recent Updates
Recently added Catalysts

Cyclosporin or tacrolimus

Phase 3

Graft Rejection | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: Mar 8, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment190
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00273871Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft RecipientsPHASE3 COMPLETED 190 — — Jan 1, 2002Sep 1, 2006Mar 8, 2011 - —
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Difference between treatment groups in renal function at 12 months.
Secondary Endpoints
Incidence of acute rejection, patient and graft survival at 12 months, labs and physical examinations, quality of life etc.
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Cyclosporin or tacrolimusDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Age over 18 * Treatment with a calcineurin inhibitor * Patients with mild to moderate renal insufficiency Exclusion Criteria: * Patients with acute rejection * Patients who received a transplant more than 10 years ago

Unlock Eligibility Criteria