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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Tacrolimus

Criteria

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