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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00758602
First received: September 24, 2008
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  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 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 Low Dose Versus Standard Dose Tacrolimus, and Corticosteroids, on Kidney Function in Renal Transplantation 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; 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 ]

Enrollment: 210
Study Start Date: October 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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
Active Comparator: 2 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

Locations
China
Beijing, China, 100020
Fuzhou, China, 350025
Guangzhou, China, 510080
Nanjing, China, 210008
Shanghai, China, 200025
Zhejiang, China, 310003
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00758602     History of Changes
Other Study ID Numbers: ML21740
Study First Received: September 24, 2008
Last Updated: May 23, 2013
Health Authority: China: State Fodd and Drug Administration

Additional relevant MeSH terms:
Mycophenolate mofetil
Tacrolimus
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 23, 2013