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Therapeutic Areas: Nephrology/Urology
Disease Category: Liver Transplantation
Trial Information
A Study of CellCept (Mycophenolate Mofetil) Combined With Calcineurin Inhibitors in Liver Transplant Patients.
Status: Recruiting
Protocol Number: ML21241
Sponsor: Hoffmann-La Roche
Company Division: Pharmaceutical
Official Scientific 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
Brief Summary: 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. Target sample size is 90.
Study Phase: IV
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Randomized
- Masking: Open Label
- Control: Active
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
Condition: Liver Transplantation
Intervention Type: Drug
Intervention Name: mycophenolate mofetil [CellCept]
Primary Outcome: 1. Glomerular filtration rate Time frame: 1 year
Key Secondary Outcomes: 1. Patient and graft survival; acute rejection episodes Time frame: Throughout study
2. AEs, laboratory parameters, liver disease, cardiovascular events, new onset of post-transplant diabetes mellitus, opportunistic infections, new onset of malignancies. Time frame: Throughout study
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.
Gender: Males or Females
Age Limits: Min: 18 Years
Accepts Healthy Volunteers: No
Anticipated Start Date: October, 2008
Trial Registration Date: 07/15/2008
Date Last Updated: 12/08/2008
Link To Trial Results
Research Site:
Located In:
Chengdu 610041
China
Phone: 973-235-5000 or 800-526-6367
View Google Map
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