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

Roche

Status and phase: Completed; Phase 4

Conditions: Liver Transplantation

Treatments: Drug: CNI (≥75%); Drug: CNI (50%); Drug: Mycophenolate mofetil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00717314

ML21241

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

MMF, 50% CNI Reduction

Experimental group

Description:

Participants received mycophenolate mofetil (MMF), 1.5 to 2.0 grams (g) daily, orally (PO), twice per day (BID) from baseline (BL) to Week 52. Participants also received a 50 percent (%) reduced dose of calcineurin inhibitor (CNI) from BL to Week 52.

Treatment:

Drug: Mycophenolate mofetil

Drug: CNI (50%)

MMF, ≥75% CNI Reduction

Experimental group

Description:

Participants received MMF, 1.5 to 2.0 g daily, PO, BID from BL to Week 52. Participants also received a 75% reduced dose of CNI from BL to Week 52.

Treatment:

Drug: Mycophenolate mofetil

Drug: CNI (≥75%)