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

A randomized open-label study of fixed-dose versus concentration-controlled mycophenolate mofetil for treatment of active lupus nephritis.

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