Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Glomerular filtration rate; chronic allograft damage.
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
China: State Fodd and Drug Administration
Study ID:
ML21740
NCT ID:
NCT00758602
Start Date:
October 2008
Completion Date:
January 2011
Related Keywords: