A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients
Phase 3
Terminated
- Conditions
- Lupus Nephritis
- Interventions
- Registration Number
- NCT01342016
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 84
Inclusion Criteria
- body weight 40-100kg
- diagnosed as systemic lupus erythematosus, (according to American College of Rheumatology Diagnostic Criteria,1997)
- diagnosed as type III/ IV of lupus nephritis by renal biopsy within 6 months
- 24hr proteinuria ≥2g and/or active urinary sediments
Exclusion Criteria
- receiving immunosuppressant
- receiving routine treatment of tacrolimus and leflunomide within 1 month
- receiving nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 months before the study
- history of allergy to tacrolimus and leflunomide
- anticipated maintenance dialysis persisted over 8 weeks; or already being dialyzed over 2 weeks before recruitment
- planning to receive kidney transplantation or in the near future or having a history of undergoing kidney transplantation
- serum creatinine (Scr) ≥3mg/dl or estimated glomerular filtration rate (eGFR) < 30ml/min
- diabetes mellitus patients
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tacrolimus group leflunomide placebo tacrolimus capsule + leflunomide placebo leflunomide group prednisone tacrolimus placebo + leflunomide tablet leflunomide group tacrolimus placebo tacrolimus placebo + leflunomide tablet leflunomide group leflunomide tablet tacrolimus placebo + leflunomide tablet tacrolimus group tacrolimus capsule tacrolimus capsule + leflunomide placebo tacrolimus group prednisone tacrolimus capsule + leflunomide placebo
- Primary Outcome Measures
Name Time Method remission rate (partial remission + complete remission) at 6 months after treatment
- Secondary Outcome Measures
Name Time Method serum albumin level at 12 weeks and 24 weeks urinary protein excretion for 24 hrs (24hr proteinuria) at 12 weeks and 24 weeks estimated glomerular filtration rate (eGFR) at 12 weeks and 24 weeks serum creatinine level at 12 weeks and 24 weeks