Clinical Trial: Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
Brief Summary: This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.
Detailed Summary:
Sponsor: Astellas Pharma Inc
Current Primary Outcome: Change of Lupus Nephritis - Disease Activity Index total score
Original Primary Outcome: Same as current
Current Secondary Outcome: proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3)
Original Secondary Outcome: Same as current
Information By: Astellas Pharma Inc
Dates:
Date Received: January 29, 2007
Date Started: June 2003
Date Completion:
Last Updated: January 29, 2007
Last Verified: January 2007