Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

Evaluation of Efficacy and Safety of Glucocorticosteroid Combined With Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of Patients With Lupus Nephritis.

Evaluation the clinical efficacy and safety profile of glucocorticosteroid combined with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of patients with lupus nephritis. Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.

Inclusion Criteria:

• Age 18-65 years with informed consent
• SLE defined by meeting 4 or more ACR classification criteria
• Biopsy-proven active proliferative lupus glomerulonephritis ISN classification Class III or IV
• Active renal disease

Exclusion Criteria:

• Pregnant, lactating or further fertility requirements
• Serum creatinine > 3 mg/dL
• Serum ALT or AST > 3 times upper limit of normal
• Severe, progressive renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease
• Previous treated with cyclophosphamide or T2.
• Not discontinuing MMF, azathioprine, leflunomide, methotrexate, calcineurin inhibitor before 1 month of randomization.
• Active or chronic infection, including HIV, HCV, HBV, tuberculosis
• Patient with malignancy