Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lupus Nephritis
Intervention: tacrolimus (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma Inc
Summary
This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study
in steroid refractory Lupus Nephritis patients.
Clinical Details
Official title: Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change of Lupus Nephritis - Disease Activity Index total score
Secondary outcome: proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3)
Eligibility
Minimum age: 16 Years.
Maximum age: 64 Years.
Gender(s): Both.
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
Locations and Contacts
Hokkaido region, Japan
Tohoku region, Japan
Kanto region, Japan
Hokuriku region, Japan
Chubu region, Japan
Kansai region, Japan
Shikoku region, Japan
Additional Information
Starting date: June 2003
Last updated: January 29, 2007
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