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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00717314

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 IV

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Parallel Assignment, Randomized, Safety/Efficacy Study, 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

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 ]

Estimated Enrollment:	90
Study Start Date:	October 2008
Estimated Study Completion Date:	May 2010

Arms	Assigned Interventions
1: Experimental	Drug: mycophenolate mofetil [CellCept] 2.0g/day po bid Drug: CNI 50% reduction from baseline
2: Experimental	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

Contacts

Contact: Please reference Study ID Number: ML21241	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

China
	Recruiting
SHANGHAI, China, 200003
	Recruiting
SHANGHAI, China, 200080
	Recruiting
CHENGDU, China, 610041
	Recruiting
Changsha, China, 410013
	Recruiting
NANJING, China, 210029
	Recruiting
GUANGZHOU, China, 510080
	Completed
BEIJING,, China, 100039
	Recruiting
Xian City, China, 710032
	Recruiting
BEIJING, China, 100054
	Recruiting
Chongqing, China, 400038

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML21241
Study First Received:	July 16, 2008
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00717314 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Anti-Bacterial Agents
Mycophenolic Acid
Mycophenolate mofetil
Immunosuppressive Agents

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Mycophenolic Acid

Mycophenolate mofetil
Enzyme Inhibitors
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 16, 2009