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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00717314
First received: July 16, 2008
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Liver Transplantation
 Drug: mycophenolate mofetil [CellCept]
Drug: CNI
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Glomerular filtration rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient and graft survival; acute rejection episodes [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, liver disease, cardiovascular events, new onset of post-transplant diabetes mellitus, opportunistic infections, new onset of malignancies. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: May 2008
Study Completion Date: February 2012
Arms Assigned Interventions
Experimental: 1 Drug: mycophenolate mofetil [CellCept]
2.0g/day po bid
Drug: CNI
50% reduction from baseline
Experimental: 2 Drug: mycophenolate mofetil [CellCept]
2.0g/day po bid
Drug: CNI
>=75% reduction from baseline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717314

Locations
China
Beijing, China, 100054
Beijing, China, 100039
Changsha, China, 410013
Chengdu, China, 610041
Chongqing, China, 400038
Guangzhou, China, 510080
Jiangsu, China, 210029
Shanghai, China, 200080
Shanghai, China, 200003
Tianjin, China, 300192
Xi'an, China, 710032
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00717314     History of Changes
Other Study ID Numbers: ML21241
Study First Received: July 16, 2008
Last Updated: May 21, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013