40
Participants
Start Date
September 30, 2012
Primary Completion Date
February 28, 2015
Study Completion Date
November 30, 2015
Everolimus
Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
Mycophenolic acid dose reduction
Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone.
University of California, San Francisco, San Francisco
University of California, San Francisco
OTHER