Table of Contents
Design
The phase III clinical program was designed to support the indication for RAPAMUNE (in combination with cyclosporine and corticosteroids) for the prophylaxis of organ rejection in patients receiving renal transplants.
Two Phase III Trials in First Renal Transplant Recipients Support the Application for Approval
Patients Continued 1-Year Follow-Up
Phase III Trials Evaluated RAPAMUNE 2 mg and 5 mg*
Study Designs of Two Phase III Trials Are Similar But Not Identical
The US Trial Was Stratified by Ethnic Origin of the Patient
Phase III US and Global Studies Included 1,295 Patients
Major Inclusion and Exclusion Criteria
Immunosuppression Regimen
Concentration-Controlled Cyclosporine Exposure
Protocol-Specified Target Trough Cyclosporine Concentrations
Similar Mean Cyclosporine Levels Across Treatment Groups
Primary Composite Endpoint
Statistical Considerations
Sample Size Determination
|