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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
0.75-1 g PO BID from Day 0 through Month 12
Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8-10 ng/mL from Day 0 through Month 3; the dose was adjusted to reach a target trough level of 7-10 ng/mL in Month 3 and continued through Month 12.
Initial dose of 0.1-0.15 mg/kg PO BID to reach a target trough dose of 8 to 10 ng/mL from Day 0 through Month 3; 0.05-0.08 mg/kg PO BID to reach a target trough dose of 2-5 ng/mL in Month 3 and continued through Month 12.
According to center's practice
Unnamed facility
Beijing, China
Unnamed facility
Fuzhou, China
Unnamed facility
Guangzhou, China
Unnamed facility
Nanjing, China
Unnamed facility
Shanghai, China
Unnamed facility
Zhejiang, China
Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation
CADI scoring was defined for 6 histological categories: interstitial inflammatory cell infiltration (0 equals (=) no or mild inflammation, 1=approximately (\~)25 percent (%) cell infiltration, 2=26-50% cell infiltration, and 3=greater than (\>)50% cell infiltration); interstitial fibrosis (0=none, 1=\~25% interstitial affected, 2=26-50% interstitial affected, and 3=\>50% interstitial affected); tubular atrophy (0=none, 1=\~15% proximal tubular atrophy \[PTA\], 2=16-30% PTA, and 3=\>30% PTA); mesangial matrix proliferation (MMP; 0=none, 1=25% non-glomerulosclerosis \[NGS\] combined with moderate MMP, 2=25-50% NGS combined with MMP, and 3=\>50% NGS combined with MMP); glomerular sclerosis (0=none, 1=\~15% glomerulus affected, 2=16-50% glomerulus affected, and 3=\>50% glomerulus affected); endothelial proliferation (EP; 0=none, 1=EP to less than (\<)25% remaining artery/small artery membrane \[RA/SAM\], 2=EP to 26-50% \[RA/SAM\], and 3=\>50% \[RA/SAM\]). CADI score was the sum of the 6 histological findings.
Time frame: Month 12
Glomerular Filtration Rate (GFR) at Month 12 After Transplantation
GFR was determined using the Cockcroft-Gault formula to calculate the creatinine clearance, at Month 12 after renal transplantation. For males, creatinine clearance \[milliliters per minute (mL/min)\] = \[(140 minus age) multiplied by (\*) (body weight in kg) divided by \[72 \* serum creatinine mg per deciliter (mg/dL)\]. For females, creatinine clearance (mL/min) = 0.85 \* \[(140 minus age) \* (body weight in kg)\] divided by \[72 \* serum creatinine (mg/dL)\].
Time frame: Month 12
Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant
Time frame: Months 6 and 12
Time to First Acute Rejection Post-Transplant - Number of Participants With an Event
Time frame: BL, Weeks 2, 4, 13, 26, 39, and 52
Time to First Acute Rejection Post-Transplant
The median time, in days, between randomization and acute rejection.
Time frame: BL, Weeks 2, 4, 13, 26, 39, and 52
Percentage of Participants With Treatment Failure at 12 Months Post-Transplant
Treatment failure was defined by the occurrence of any of the following: use of additional maintenance immunosuppressive medication not specified in the assigned treatment group; discontinuation of any of the assigned immunosuppressants for more than 14 consecutive days or 30 cumulative days; graft loss or return to chronic dialysis; or death.
Time frame: Month 12
Participant and Graft Survival
The percentage of participants surviving with grafts intact at 6 and 12 months after renal transplant.
Time frame: Months 6 and 12
Serum Creatinine (Micromoles Per Liter [µmol/L])
The mean serum creatinine values in µmol/L at Baseline (BL), Weeks 2, 4, 13, 26, 39, and 52.
Time frame: BL, Weeks 2, 4, 13, 26, 39, and 52
Glomerular Filtration Rate (GFR) (mL/Min)
The mean GFR values in mL/min at BL, Weeks 2, 4, 13, 26, 39, and 52.
Time frame: BL, Weeks 2, 4, 13, 26, 39, and 52
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