A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients

A Randomized, Double-blind Double Dummy, Parallel Control and Multi-center Clinical Trial to Compare the Efficacy and Safety of Tacrolimus Capsules in Treatment of Lupus Nephritis With Leflunomide Tablets

The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.

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