Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Nephritis, Lupus

Treatments: Drug: Tripterygium wilfordii Hook F; Drug: Cyclophosphamide; Drug: GC

Study type: Interventional

Funder types: Other

Identifiers

NCT01646736

T2WILN

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups, including a placebo group

GC+CYC

Placebo Comparator group

Description:

Patients were treated with Glucocorticosteroid and Cyclophosphamide.

Treatment:

Drug: Cyclophosphamide

Drug: GC

GC+T2

Experimental group

Description:

Patients were treated with Glucocorticosteroid and oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).

Treatment:

Drug: Tripterygium wilfordii Hook F

Drug: GC