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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Calcineurin Inhibitors; Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• single organ recipients of liver allograft;

• CNI-based immunosuppressive regimen prior to study entry and regimen adjustment;

• >=6 months post-transplant, with renal dysfunction (serum creatinine 140-300micromol/L at entry);

• negative pregnancy test for women of childbearing potential; contraception must be taken before beginning study drug therapy and until 6 weeks after last dose of study medication.

Exclusion Criteria:

• treatment with CellCept or any other product which delivers mycophenolic acid within the 3 months prior to the recent switch to CellCept relevant for enrollment;

• known contraindications to CNI, corticosteroids or CellCept.