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Completed

NCT Number: NCT00717314

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

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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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mycophenolate mofetil

Drug

1.5 to 2.0 g daily PO BID

Other names: CellCept

CNI (50%)

Drug

50% reduction from BL

CNI (≥75%)

Drug

≥75% reduction from BL

Primary outcomes

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

    Time frame: Week 52

    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.

Secondary outcomes

  1. Percentage of Participants With Graft Loss or Death at Week 52

    Time frame: Week 52

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

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

    Time frame: Week 52

    BPAR was graded according to Banff criteria.

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

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

    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).

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

    Time frame: 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).

  5. Percentage Change in Creatinine Clearance From Baseline

    Time frame: Weeks 16, 28, 40, and 52

    Creatinine clearance was calculated using the Cockcroft and Gault formula.

  6. Percentage of Participants Experiencing Acute Rejection, Graft Loss, Death, or a Decrease From BL in Creatinine Clearance of ≥20% at Week 52

    Time frame: Week 52

    The percentage of participants who experienced at least 1 of the following: a ≥20% decrease from BL in creatinine clearance, acute rejection, graft loss, or death 1 year after randomization.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Open Label Study Comparing the Effect of CellCept Combined With 2 Regimens of Reduced Calcineurin Inhibitors on Kidney Function in Liver Transplant Patients

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 17, 2008
Registry last updated
Sep 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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