Title
Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis
A Randomized Open-label Study of Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis
Phase
Phase 4Lead Sponsor
Chulalongkorn UniversityStudy Type
InterventionalStatus
TerminatedIndication/Condition
Lupus NephritisIntervention/Treatment
Mycophenolate MofetilStudy Participants
2A randomized open-label study of fixed-dose versus concentration-controlled mycophenolate mofetil for treatment of active lupus nephritis.
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.
MMF will be prescribed at a starting dose of 1.5 g/day and increased to 2 g/day at week 4 (if body weight ≥ 45 kg) and continue the same dose until week 24. After week 24, MMF will be lowered to 1.5 g/day.
MMF will be prescribed at a starting dose of 1.5 g/day. MPA-C0 (trough) level will be measured weekly and MMF dose will be increased by 500 mg/day every week until the MPA-C0 level ≥ 3 mg/L or the MMF dosage is 3000 mg/day. After achieving the targeted MPA-C0 level, the MMF dose adjustment will be allowed only if the MPA-C0 levels are lower than 3 mg/L for two consecutive monitoring visits. After week 12, MMF will be maintained at the same dose until week 48
Inclusion Criteria: Age 18-65 year Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE Active lupus nephritis (both new and flare patients can be included) defined as: Within 16 weeks of randomization, had Biopsy-proven ISN class III or IV [exclude III(c), IV-S(c) and IV-G(c). Patients are permitted to have co-existing class V and At screening day, has urine protein creatinine ratio (UPCR) or 24-hour urinary protein ≥ 1.0 g/g or g/day Exclusion Criteria: Pregnancy or breast feeding Child-bearing age women who refuse to use effective birth-control Poor compliance Estimated-GFR < 20 mL/min/1.73 m2 Crescentic glomeruli more than 30 percent Severe extra-renal involvement of SLE History of severe allergic reactions or adverse effects to MMF Uncontrolled concomitant disease Known active, clinically significant infection of any kind History of serious recurrent or chronic infection History of malignancy (except basal cell carcinoma, squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been excised and cured) Concomitant conditions which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) at any time in the 52 weeks prior to screening Treatment with more than 1 g cyclophosphamide within the past 24 weeks Receipt more than 3 g of IV pulse methylprednisolone within the past 12 weeks Receipt prednisolone more than 30 mg/day for longer than 30 days within the past 12 weeks Treatment with MMF at ≥ 1.5 g/day for over 4 weeks within the past 12 weeks On treatment with Tacrolimus or Cyclosporine on the day of screening Treatment with any biologic B-cell depleting therapy (e.g. anti CD-20, anti CD 22) within 52 weeks Receiving concomitant medication interfering PK of MPA Cholestyramine Rifampin
