A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00758602

Purpose

This 2 arm study will compare the efficacy and safety of CellCept, combined with low or standard dose tacrolimus plus corticosteroids, in patients with kidney transplants. Patients will be randomized into one of 2 groups to receive either 1)CellCept 2.0g/day po bid + tacrolimus 10-12ng/mL followed by a maintenance dose of 8-10ng/mL + corticosteroids or 2)CellCept 2.0g/day po bid + tacrolimus 8-10ng/mL in the first 2 months,3-7ng/mL in month 3 followed by a maintenance dose of 3-5ng/mL + corticosteroids. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Kidney Transplantation	Drug: mycophenolate mofetil [CellCept] Drug: tacrolimus Drug: corticosteroids	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open Label Study Comparing the Effect of CellCept Combined With Low Dose Versus Standard Dose Tacrolimus, and Corticosteroids, on Kidney Function in Renal Transplantation Patients

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus anhydrous Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Corticosteroids

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Glomerular filtration rate; chronic allograft damage. [ Time Frame: 12 months ] [ 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, renal disease, cardiovascular events, opportunistic infections, new onset of malignancies. [ Time Frame: Throughout study. ] [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	September 2008
Estimated Study Completion Date:	December 2010

Arms	Assigned Interventions
1: Experimental	Drug: mycophenolate mofetil [CellCept] 2.0g/day po bid Drug: tacrolimus 8-10ng/mL in first 2 months,3-7ng/mL in month 3,followed by maintenance dose of 3-5ng/mL Drug: corticosteroids As prescribed
2: Active Comparator	Drug: mycophenolate mofetil [CellCept] 2.0g/day po bid Drug: tacrolimus 10-12ng/mL in first 3 months, followed by maintenance dose of 8-10ng/mL Drug: corticosteroids As prescribed

Eligibility

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, <=75 years of age;
single organ recipients of renal allograft;
negative pregnancy test for women of childbearing potential; reliable contraception must be used before starting drug therapy, until 6 weeks after the last dose of study medication.

Exclusion Criteria:

severe gastrointestinal disease which may influence the absorption of oral drug therapy;
severe infection, HIV or active hepatitis;
active gastric ulcers;
malignancy other than cured skin cancer;
severe anemia, leucopenia or thrombocytopenia.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758602

Contacts

Contact: Please reference Study ID Number: ML21740	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

United States, Nebraska
	Not yet recruiting
OMAHA, Nebraska, United States, 68114
China
	Recruiting
SHANGHAI, China, 200025
	Recruiting
ZHEJIANG, China, 310003
	Recruiting
NANJING, China, 210008
	Recruiting
FUZHOU, China, 350025
	Recruiting
BEIJING, China, 100020
	Recruiting
GUANGZHOU, China, 510080
Taiwan
	Not yet recruiting
TAICHUNG, Taiwan, 407
	Not yet recruiting
TAOYUAN, Taiwan, 333
	Not yet recruiting
TAINAN, Taiwan, 704
	Not yet recruiting
TAICHUNG, Taiwan, 402

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:	ML21740
Study First Received:	September 24, 2008
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00758602 History of Changes
Health Authority:	China: State Fodd and Drug Administration

Study placed in the following topic categories:

Anti-Bacterial Agents
Immunologic Factors
Mycophenolic Acid

Mycophenolate mofetil
Tacrolimus
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
Tacrolimus
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009