58
Participants
Start Date
January 31, 2008
Primary Completion Date
November 11, 2011
Study Completion Date
December 31, 2011
Kidney Biopsy
Skin over the kidney will be cleansed and disinfected. The skin and deeper tissue will be numbed with novocaine like solution. A special needle will be inserted guided by ultrasound into the kidney for an instant to withdraw the small specimen.
Rapamune (sirolimus/rapamycin)
Rapamune will be given at a dose of 5mg/day for two days beginning at the initiation of tacrolimus reduction. Thereafter, Rapamune will be given at a dose of 3 mg/day. The dose of Rapamune will be titrated to achieve a blood level (by HPLC) between 5 and 10 for the duration of the study.
Tacrolimus
Patients in this group will continue to receive tacrolimus at reduced doses. Doses will be titrated to achieve tacrolimus trough blood levels between 4 and 6. Myfortic at doses of 720 mg BID and steroids will be continued for the duration of the study (12 months).
Buffalo General Hospital Multi-Organ Transplant Department, Buffalo
Collaborators (1)
Novartis
INDUSTRY
University of Washington
OTHER
University at Buffalo
OTHER