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

Hoffmann-La Roche87 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Transplantation

Interventions

Mycophenolate mofetilDRUG

1.5 to 2.0 g daily PO BID

CNI (50%)DRUG

50% reduction from BL

CNI (≥75%)DRUG

≥75% reduction from BL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Unnamed facility

Beijing, China

Unnamed facility

Beijing, China

Unnamed facility

Changsha, China

Unnamed facility

Chengdu, China

Outcomes

Primary Outcomes

Percentage of Participants With Decrease in Glomerular Filtration Rate (GFR) of Greater Than 20%

The percentage of participants with a greater than 20% decrease of GFR during the 1-year period following regimen adjustment. Cockcroft and Gault formula was used for calculated creatinine clearance.

Time frame: Week 52

Secondary Outcomes

Percentage of Participants With Graft Loss or Death at Week 52

Graft loss was defined for this protocol as re-transplantion or death.

Time frame: Week 52

Percentage of Participants With Biopsy-Proven Acute Rejection (BPAR) at Week 52

BPAR was graded according to Banff criteria.

Time frame: Week 52

Changes From Baseline in Creatinine Clearance (Milliliters Per Minute [mL/Min])

Creatinine clearance calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min equaled (=) \[(140 minus (-) age in years) multiplied by (\*) (weight in kilograms (kg)\] divided by \[72 \* serum creatinine in milligrams per deciliter (mg/dL)\]. For adult females, creatinine clearance in mL/min = 0.85 \* \[(140 - age in years) \* (weight in kg)\] divided by (72 \* serum creatinine in mg/dL).

Time frame: Baseline and Weeks 16, 28, and 40

Change From Baseline in Corrected Creatinine Clearance (mL/Min) at Week 52

Corrected creatinine clearance was calculated using the Cockcroft and Gault formula: For adult males, creatinine clearance in mL/min = \[(140 - age in years) \* (weight in kg\] divided by \[72 \* serum creatinine in mg/dL\]. For adult females, creatinine clearance in mL/min = 0.85 \* \[(140 - age in years) \* (weight in kg)\] divided by (72 \* serum creatinine in mg/dL).

Time frame: Week 52

Data from ClinicalTrials.gov

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