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

Phase 3

Completed

• Conditions: Lupus Nephritis

• Registration Number: NCT00429377
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Status Verified: 2007-01
• Study First Submitted: 2007-01-29
• Study First Submitted QC: 2007-01-29
• Last Update Submitted: 2007-01-29
• Study First Posted: 2007-01-31
• Last Update Posted: 2007-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of Lupus Nephritis - Disease Activity Index total score

Secondary Outcome Measures

Name	Time	Method
proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3)