Lupus Nephritis
Conditions
Brief summary
A randomized open-label study of fixed-dose versus concentration-controlled mycophenolate mofetil for treatment of active lupus nephritis.
Interventions
DRUGMycophenolate Mofetil
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.
Sponsors
Berlin Pharmaceutical Industry
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate at 48 week of therapy | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Mycophenolic acid trough levels | 48 weeks |
| MPA-area under the curve (AUC) 0-4 hour at 12 week | 12 weeks |
| C3 levels | 48 weeks |
| Urine IP-10 levels | 48 weeks |
| Adverse events | 48 weeks |
| Relapse free survival at 96, 144 and 240 week | 96, 144 and 240 weeks |
| eGFR at 96, 144 and 240 week | 96, 144 and 240 weeks |
| Progression to CKD stage 3 or more at 96, 144 and 240 week | 96, 144 and 240 weeks |
| End stage renal disease at 96, 144 and 240 week | 96, 144 and 240 weeks |
| Anti-dsDNA | 48 weeks |
Countries
Thailand
Outcome results
None listed