Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Cyclophosphamide

Criteria

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