Rapamycin derivative (RAD) is a macrolide metabolite with potent and unique immunosuppressive properties. RADB 158 is a one year multicenter investigation of the safety, pharmacokinetics and efficacy of RAD in De Novo liver transplant recipients. Subjects will receive one of the four dose regimens (three treatment groups and one placebo group) and will be randomized 1:1:1:1. Treatment will be double-blind and will continue for 12 months post-transplant. Subjects will receive RAD study drug/placebo in combination with cyclosporine and steriods and will not receive anti-lymphocyte induction. Patients will be screened prior to transplant and randomized immediately post-transplant. RADB will be formulated as oral tablets and administered twice daily with Neoral cyclosporine. Patients will undergo frequent safety laboratory assessments and three 12-hour pharmacokinetc sessions at day 7, month 2 and month 3 post-transplant.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000042-40
Application #
6408499
Study Section
General Clinical Research Centers Committee (CLR)
Project Start
1977-12-01
Project End
2001-02-28
Budget Start
Budget End
Support Year
40
Fiscal Year
2000
Total Cost
Indirect Cost
Name
University of Michigan Ann Arbor
Department
Type
DUNS #
791277940
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
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