A randomized open-label study of fixed-dose versus concentration-controlled mycophenolate mofetil for treatment of active lupus nephritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Description Each capsule contains Mycophenolate mofetil 250 mg. Presentation / Packing Cap 250 mg (white to off white powder, light blue/peach hard gelatin, imprinting with "MMF" on cap and "250" on body) x 10 x 10's. Storage Store below 30 degree Celcius.
King Chulalongkorn Memorial Hospital
Bangkok, Please Select, Thailand
Response rate at 48 week of therapy
Time frame: 48 weeks
Adverse events
Time frame: 48 weeks
Mycophenolic acid trough levels
Time frame: 48 weeks
MPA-area under the curve (AUC) 0-4 hour at 12 week
Time frame: 12 weeks
C3 levels
Time frame: 48 weeks
Urine IP-10 levels
Time frame: 48 weeks
Anti-dsDNA
Time frame: 48 weeks
Relapse free survival at 96, 144 and 240 week
Time frame: 96, 144 and 240 weeks
eGFR at 96, 144 and 240 week
Time frame: 96, 144 and 240 weeks
Progression to CKD stage 3 or more at 96, 144 and 240 week
Time frame: 96, 144 and 240 weeks
End stage renal disease at 96, 144 and 240 week
Time frame: 96, 144 and 240 weeks
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