Clinical trial NCT00758602: A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 210
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation
timeFrame: Month 12
measure: Glomerular Filtration Rate (GFR) at Month 12 After Transplantation
timeFrame: Month 12
Secondary outcomes:
measure: Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant
timeFrame: Months 6 and 12
measure: Time to First Acute Rejection Post-Transplant - Number of Participants With an Event
timeFrame: BL, Weeks 2, 4, 13, 26, 39, and 52
measure: Time to First Acute Rejection Post-Transplant
timeFrame: BL, Weeks 2, 4, 13, 26, 39, and 52
measure: Percentage of Participants With Treatment Failure at 12 Months Post-Transplant
timeFrame: Month 12
measure: Participant and Graft Survival
timeFrame: Months 6 and 12
measure: Serum Creatinine (Micromoles Per Liter [µmol/L])
timeFrame: BL, Weeks 2, 4, 13, 26, 39, and 52
measure: Glomerular Filtration Rate (GFR) (mL/Min)
timeFrame: BL, Weeks 2, 4, 13, 26, 39, and 52
Other outcomes:
Locations:
city: Beijing
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Zhejiang
country: China
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: