Trial Information

Summary: 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

Trial Registration Date: 07/15/2008

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Changsha, China, 410011
Telephone: 973-235-5000 or 800-526-6367

  

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Trial listings updated: September 2, 2008 at 2:18:14 PM


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