165
Participants
Start Date
April 30, 2001
Primary Completion Date
November 30, 2007
Study Completion Date
December 31, 2008
Anti-thymocyte globulin
Thymoglobulin 1.5 mg/kg/d (days 0,1,2,4,6)
Mycophenolate mofetil
Mycophenolate mofetil 750 mg p.o. b.i.d.- maintenance
Prednisone
Prednisone 500 mg/day initially, tapered to 5 mg/day by day 92
Tacrolimus
Tacrolimus - maintain trough levels of 6-8 ng/ml (whole blood Imx assay)
Sirolimus
Rapamycin 3 to 5 mg/day; adjust to the high-performance liquid chromatography (HPLC) blood level 15 to 20 ng ml
Mayo Clinic, Rochester
Lead Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Genzyme, a Sanofi Company
INDUSTRY
Roche Pharma AG
INDUSTRY
Mayo Clinic
OTHER