A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.
Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
This 2 arm study will compare the efficacy and safety of CellCept, combined with low or
standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients
will be randomized into one of 2 groups to receive either 1)CellCept 2.0g/day po bid +
tacrolimus 10-12ng/mL followed by a maintenance dose of 8-10ng/mL + corticosteroids or
2)CellCept 2.0g/day po bid + tacrolimus 8-10ng/mL in the first 2 months,3-7ng/mL in month 3
followed by a maintenance dose of 3-5ng/mL + corticosteroids. The anticipated time on study
treatment is 1 year, and the target sample size is 100-500 individuals.