223
Participants
Start Date
May 31, 2006
Primary Completion Date
February 28, 2009
Study Completion Date
February 28, 2009
Everolimus 0.25 and 0.75 mg tablets
The dose of everolimus for each patient was adjusted to achieve the target everolimus blood level range. Everolimus blood trough level was measured 5 days after any dose adjustment to verify that the blood level was within the desired target level range.
Cyclosporine very low dose (150-300 ng/mL) microemulsion
The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose.
Cyclosporine low dose (350-500 ng/mL) microemulsion
The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose.
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY