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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MMF, 50% CNI Reduction

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.

Group Type EXPERIMENTAL

Mycophenolate mofetil

Intervention Type DRUG

1.5 to 2.0 g daily PO BID

CNI (50%)

Intervention Type DRUG

50% reduction from BL

MMF, ≥75% CNI Reduction

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.

Group Type EXPERIMENTAL

Mycophenolate mofetil

Intervention Type DRUG

1.5 to 2.0 g daily PO BID

CNI (≥75%)

Intervention Type DRUG

≥75% reduction from BL

Interventions

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Mycophenolate mofetil

1.5 to 2.0 g daily PO BID

Intervention Type DRUG

CNI (50%)

50% reduction from BL

Intervention Type DRUG

CNI (≥75%)

≥75% reduction from BL

Intervention Type DRUG

Other Intervention Names

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CellCept

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No