Phase 3 Study of Tacrolimus (FK506) for Lupus Nephritis: A Placebo Controlled, Double-Blind Multicenter, Comparative Study

Astellas

Status and phase: Completed; Phase 3

Conditions: Lupus Nephritis

Treatments: Drug: tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00429377

506-LN02

Details and patient eligibility

About

This study consists of a 28-week placebo-controlled double-blind inter-group efficacy study in steroid refractory Lupus Nephritis patients.

Sex: All

Ages: 16 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind