Trial information
A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.
Status: Recruiting
Protocol number: ML21740
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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
Brief summary: 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. Target sample size is
210.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Kidney Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil [CellCept]
Primary outcome: 1. Glomerular filtration rate; chronic allograft damage. Time frame: 12 months
Key secondary outcomes: 1. Patient and graft survival; acute rejection episodes. Time frame: Throughout study
2. AEs, laboratory parameters, renal disease, cardiovascular events, opportunistic infections, new onset of malignancies. Time frame: Throughout study.
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.
Gender: Males or Females
Age limits: Min: N/A (No limit) Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: September, 2008
Trial registration date: 09/23/2008
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
China
- Beijing
- Fuzhou
- Guangzhou
- Nanjing
- Shanghai
- Zhejiang
