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