To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as compared to intravenous cyclophosphamide in the treatment of active nephritis. The primary outcomes are complete and partial renal remission, as assessed by renal function, urinary sediment and proteinuria in patients with International Society of Nephrology/ Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis.
In this study, there are two sub-studies in order to define secondary endpoints. 1. Pharmacokinetics study of Mycophenolic acid 2. Identify biomarkers for therapy-resistant prediction. 3. Identify biomarkers for predicting a loss of kidney function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
per oral, twice daily, for 12 months
intravenous, monthly, for 6 months
Khon Kaen University
Khon Kaen, Changwat Khon Kaen, Thailand
Nopparat Rajathani
Bangkok, Thailand
Thammasart University
Pathum Thani, Thailand
Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis
Time frame: 12 months
The cost-effectiveness of using enteric-coated Mycophenolate Sodium as compared to standard treatment
Time frame: 12 months
The ratio of patients with declined renal function
Time frame: 12 months
Time to remission
Time frame: 12 months
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