A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.

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

Outcome

Missed primary endpoint

registry analysis (superiority or other test); MMF, 50% CNI vs MMF, 75% CNI; p = 0.494; ANOVA NCT00717314 ↗

Drugs

Indications

No indication recorded.