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

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma China, Inc.
• Treatments: Leflunomide; Prednisone; Tacrolimus

Criteria

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