Status:
COMPLETED
Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Lupus Nephritis
Eligibility:
All Genders
16-64 years
Phase:
PHASE3
Brief Summary
This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00429377
Start Date
June 1 2003
Last Update
January 31 2007
Active Locations (7)
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1
Chubu Region, Japan
2
Hokkaido Region, Japan
3
Hokuriku Region, Japan
4
Kansai Region, Japan