Back to resultsPhase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
Primary Purpose
Lupus Nephritis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring tacrolimus, FK506, lupus nephritis
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Change of Lupus Nephritis - Disease Activity Index total score
Secondary Outcome Measures
proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00429377
Brief Title
Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
Official Title
Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
5. Study Description
Brief Summary
This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis
Keywords
tacrolimus, FK506, lupus nephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
64 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Primary Outcome Measure Information:
Title
Change of Lupus Nephritis - Disease Activity Index total score
Secondary Outcome Measure Information:
Title
proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Chubu region
Country
Japan
City
Hokkaido region
Country
Japan
City
Hokuriku region
Country
Japan
City
Kansai region
Country
Japan
City
Kanto region
Country
Japan
City
Shikoku region
Country
Japan
City
Tohoku region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
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