drugset / Trial / NCT00717314
A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.
RandomizedParallel-groupOpen-labelTreatment
Summary
This 2 arm study will compare the efficacy and safety of switching to CellCept combined with different regimens of reduced calcineurin inhibitors (CNI) in patients with liver transplants. Patients currently receiving CNI treatment will be randomized into one of 2 groups to receive either 1) CellCept 2.0g/day po bid + 50% reduction of CNI from baseline or 2) CellCept 2.0g/day po bid + \>=75% reduction of CNI from baseline. The anticipated time on study treatment is 1 year, and the target sample size is \<100 individuals.
Timeline
- Start
- 2008-05
- Primary completion
- 2011-07
- Completion
- 2011-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 1.5 g | Oral |
| Subject | Mycophenolate Mofetil | Small molecule | 2 g | Oral |
Indications
No indication recorded.