A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy 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

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-07-31

Brief Summary

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This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients. Patients will be randomized into one of two groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed dose CellCept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day 0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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, Adjusted Dose; Tacrolimus; Corticosteroids

Participants received mycophenolate mofetil (MMF) 3 grams per day (g/d), orally (PO), twice per day (BID) with meals from Day 0 to Day 4; the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12. Participants also received tacrolimus adjusted to a target trough level of 8 to (-) 12 nanograms per milliliter (ng/mL) from Day 0 to Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received corticosteroids 10-15 milligrams per kilogram (mg/kg), intravenously (IV), pre-operation on Day 0.

Group Type EXPERIMENTAL

Mycophenolate mofetil, adjusted dose

Intervention Type DRUG

3 g/d PO BID during meals from Day 0 to Day 4, followed by dose adjustment based on AUC using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12.

Tacrolimus

Intervention Type DRUG

Target trough level of 8-2 ng/mL from Day 0 to Month 1, adjusted to a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12

Corticosteroids, IV

Intervention Type DRUG

10-15 mg/kg IV pre-operation on Day 0

MMF, Standard Dose; Tacrolimus; Corticosteroids

Participants received MMF 2 g/d, PO, BID with meals from Day 0 to Month 12. Participants also received tacrolimus adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received corticosteroids 10-15 mg/kg, IV, pre-operation on Day 0; followed by 20 mg/d, PO, 4 times per day (QDS) from Day 0 through Month 1; 15 mg/d, PO, 3 times per day (TID) from the end of Month 1 through Month 2; 10 mg/d, PO, BID from the end of Month 2 through Month 3; and 5 mg/d once per day from the end of Month 3 through Month 6.

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

Target trough level of 8-2 ng/mL from Day 0 to Month 1, adjusted to a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12

Corticosteroids, IV

Intervention Type DRUG

10-15 mg/kg IV pre-operation on Day 0

Mycophenolate mofetil, Standard dose

Intervention Type DRUG

2 g/d PO BID during meals from Day 0 to Month 12

Corticosteroids, PO

Intervention Type DRUG

20 mg/d QDS from Day 0 through Month 1; 15 mg/day, TID from the end of Month 1 through Month 2; 10 mg/d BID from the end of Month 2 through Month 3; and 5 mg/d once per day from the end of Month 3 through Month 6.

Interventions

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Mycophenolate mofetil, adjusted dose

3 g/d PO BID during meals from Day 0 to Day 4, followed by dose adjustment based on AUC using the Bayesian method with limited sampling strategy on Days 5 and 14, Months 1, 13, 6, 9, and 12.

Intervention Type DRUG

Tacrolimus

Target trough level of 8-2 ng/mL from Day 0 to Month 1, adjusted to a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12

Intervention Type DRUG

Corticosteroids, IV

10-15 mg/kg IV pre-operation on Day 0

Intervention Type DRUG

Mycophenolate mofetil, Standard dose

2 g/d PO BID during meals from Day 0 to Month 12

Intervention Type DRUG

Corticosteroids, PO

20 mg/d QDS from Day 0 through Month 1; 15 mg/day, TID from the end of Month 1 through Month 2; 10 mg/d BID from the end of Month 2 through Month 3; and 5 mg/d once per day from the end of Month 3 through Month 6.

Intervention Type DRUG

Other Intervention Names

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CellCept Solu-Medrol CellCept Cortancyl

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* recipient of a first orthotopic liver transplant.

Exclusion Criteria

* history of organ transplants;
* patient receiving a multi-organ transplant;
* calculated creatinine clearance \<=30mL/min before transplant;
* leukocyte count \< 2000/mm3 at randomization;
* history of cancer within past 5 years, except for successfully treated basal cell or squamous cell cancer, or in situ cervical cancer;
* pregnant or breast-feeding females, or females of childbearing age not using effective contraception.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No