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
- 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
- severe gastrointestinal disease which may influence the absorption of oral drug
- severe infection, HIV or active hepatitis;
- active gastric ulcers;
- malignancy other than cured skin cancer;
- severe anemia, leucopenia or thrombocytopenia.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Glomerular filtration rate; chronic allograft damage.
Outcome Time Frame:
China: State Fodd and Drug Administration