This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.
This study is designed to compare the two different doses of Mycocep Capsules (1.0g/day \& 1.5g/day) and Imuran Azathioprine Tablets (2mg/kg/day), all in combination with low-dose prednisolone (≤10mg/day) as maintenance treatment for lupus nephritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.
Provided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks.
Daily dose not more than 10mg, orally, for 24 weeks.
Change in serum albumin
Time frame: 24 weeks treatment
Change in serum creatinine
Time frame: 24 weeks treatment
Change in spot urine protein/creatinine ratio
Time frame: 24 weeks treatment
Change in serum albumin
Time frame: 12 weeks treatment
Change in serum creatinine
Time frame: 12 weeks treatment
Change in spot urine protein/creatinine ratio
Time frame: 12 weeks treatment
Change in cholesterol
Time frame: 24 weeks treatment
Change in triglyceride
Time frame: 24 weeks treatment
Change in complete blood count/differential count (CBC/DC)
Time frame: 24 weeks treatment
Change in number of subjects with doubling of serum creatinine
Time frame: 24 weeks treatment
Change in the average daily dose of oral prednisolone
Time frame: 24 weeks treatment
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