The primary objective of this study is to evaluate the safety and tolerability of multiple oral doses (once daily for 28 days) of FTY720 in stable renal transplant patients during steady state administration of Neoral. (cyclosporine for microemulsion) and prednisone. Secondary objectives include: measurement of the pharmacokinetics of whole blood FTY720 concentration after multiple oral doses, determination of the pharmacodynamic effect of multiple rising oral doses of FTY720 on lymphocyte counts and to measure the effect of FTY720 on lymphocyte subsets and to assess the effects of multiple once-daily oral doses of FTY720 on the steady state pharmacokinetics of cyclosporine.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000034-40
Application #
6404664
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1976-12-01
Project End
2001-11-30
Budget Start
Budget End
Support Year
40
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Ohio State University
Department
Type
DUNS #
098987217
City
Columbus
State
OH
Country
United States
Zip Code
43210
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