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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Liver Transplantation

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Glomerular filtration rate

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

China: Food and Drug Administration

Study ID:

ML21241

NCT ID:

NCT00717314

Start Date:

May 2008

Completion Date:

February 2012

Related Keywords:

  • Liver Transplantation

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