NCT00717314

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

A Randomized, Open Label Study Comparing the Effect of CellCept Combined With 2 Regimens of Reduced Calcineurin Inhibitors on Kidney Function in Liver Transplant Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
DRUG	Mycophenolate mofetil	1.5 to 2.0 g daily PO BID
DRUG	CNI (50%)	50% reduction from BL
DRUG	CNI (≥75%)	≥75% reduction from BL

Timeline

• Start date: 2008-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2008-07-17
• Last updated: 2014-09-29
• Results posted: 2014-09-29

Locations

11 sites across 1 country: China