Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study

Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study

This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.

Inclusion Criteria:

• Steroid refractory lupus nephritis

  • more than 10mg of steroid failed to control disease activity
  • patients who failed to reduce the amount of steroid
  • patients who couldn't increase the amount of steroid due to side effects

Exclusion Criteria:

• Patients who started the immunosuppressant therapy or increased the amount of immunosuppressant within 12 weeks prior to test drug administration
• Patients who received cyclophosphamide puls within 24 weeks prior to test drug administration
• CNS( Central Nerve System) Lupus patients
• hepatic failure patients
• Serum creatinine ≧1.5mg/dL