180
Participants
Start Date
November 30, 2007
Primary Completion Date
July 31, 2011
Study Completion Date
July 31, 2011
Mycophenolate mofetil, adjusted dose
3 g/d PO BID during meals from Day 0 to Day 4, followed by dose adjustment based on AUC using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12.
Tacrolimus
Target trough level of 8-2 ng/mL from Day 0 to Month 1, adjusted to a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12
Corticosteroids, IV
10-15 mg/kg IV pre-operation on Day 0
Mycophenolate mofetil, Standard dose
2 g/d PO BID during meals from Day 0 to Month 12
Corticosteroids, PO
20 mg/d QDS from Day 0 through Month 1; 15 mg/day, TID from the end of Month 1 through Month 2; 10 mg/d BID from the end of Month 2 through Month 3; and 5 mg/d once per day from the end of Month 3 through Month 6.
Marseille
Caen
Besançon
Toulouse
Bordeaux
Montpellier
Rennes
Grenoble
Lille
Lyon
Lyon
Paris
Clichy
Créteil
Villejuif
Nice
Hoffmann-La Roche
INDUSTRY