This 2 arm study will compare the efficacy and safety of CellCept plus corticosteroids, versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine in the maintenance phase, in maintaining remission and renal function in patients with lupus nephritis. Patients will be randomized to receive CellCept 1g bid po plus corticosteroids for 24 weeks, followed by CellCept 0.75g bid po plus corticosteroids for the following 24 weeks, or cyclophosphamide 0.5-1.0g/m2 monthly plus corticosteroids for 24 weeks, followed by azathioprine 2mg/kg/day po plus corticosteroids for the following 24 weeks. Response rate will be assessed at the end of the induction phase, and at the end of study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
0.5 g PO BID from Day 0 to the end of Week 1, followed by 1.0 g PO BID from Weeks 2 through 24, and 0.75 g PO BID from Weeks 32 to 48
0.75 to 1.0 mg/kg/d PO (up to 60 kg/day) from Weeks 1 through 4; reduced by 10 mg/day every 2 weeks until dose reaches 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reaches 10 mg/day up to Week 48
100 mg PO daily for participants with a body weight of 50 to 70 kg,150 mg PO daily for subjects with a body weight of more than 70 kg up to Week 48
0.75 g/m\^2 IV every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m\^2 to maintain a minimum WBC count of ≥ 2500 per mm\^3 from Weeks 5 through 24
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Beijing, China
Unnamed facility
Guangzhou, China
Unnamed facility
Guangzhou, China
Unnamed facility
Hangzhou, China
Unnamed facility
Nanjing, China
Unnamed facility
Shanghai, China
Unnamed facility
Shanghai, China
Unnamed facility
Shanghai, China
...and 1 more locations
Complete Response (CR) by the End of Treatment - Percentage of Participants With an Event
CR was defined as a urinary protein value of less than (\<) 500 mg per 24 hours (mg/24h) and no hematuria or cellular casts in the urine, and a stable serum creatinine value within the range of plus or minus (±) 25 percent (%) of baseline (BL) or some improvement.
Time frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Complete Response
The median time, in months, to CR was defined as the time from randomization to CR event.
Time frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Percentage of Participants With Treatment Response Event by End of Treatment
Treatment response was defined by a reduction in the ratio of urine protein to creatinine to \<3 mg/mg for participants with nephrotic proteinuria and a decrease of more than 50% in their urine protein to creatinine value from BL for participants with non-nephrotic proteinuria; a stable serum creatinine value or an increase of more than 30% from BL; and having not received IV prednisone after Week 28.
Time frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Percentage of Participants With a Decrease of 25% or 50% in Glomerular Filtration Rate (GFR)
GFR was calculated according to the simplified modification of diet in renal disease (MDRD) formula.
Time frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Percentage of Participants Terminating Treatment
Time frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Time to Treatment Failure
Treatment failure was defined as the occurrence of any of the following: death; chronic renal failure requiring dialysis or kidney transplantation; an increase in average serum creatinine values by 2-fold for 2 consecutive measures from BL, and a increase by 2-fold for 2 consecutive measures in at least 4 weeks; recurrent kidney disease defined by, proteinuria, a doubling in the ratio of urine protein to creatinine from BL and a urinary protein value of \<0.5 g/24h or greater than (\>) 1 g/24h or \>0.5 g/24h or \>2 g/24h at Week 24, kidney disease, defined by an increase in serum creatinine of 25% from BL along with a doubling of urinary protein of at least 2 g/24h, and hematuria, 2 or more blood cells per urine dipstick test.
Time frame: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
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