Lupus Nephritis Clinical Trial
Official title:
Phase 3 Study of Tacrolimus(FK506)for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study
| NCT number | NCT00429377 |
| Other study ID # | 506-LN02 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | January 29, 2007 |
| Last updated | January 29, 2007 |
| Start date | June 2003 |
| Verified date | January 2007 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.
| Status | Completed |
| Enrollment | 64 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 16 Years to 64 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of Lupus Nephritis - Disease Activity Index total score | |||
| Secondary | proteinuria, RBC-urine, serum creatinine, anti ds-DNA antibody, complement (C3) |
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