Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Nephritis, Lupus

Intervention / Treatment
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* Drug: Tripterygium wilfordii Hook F
* Drug: Cyclophosphamide
* Drug: GC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: GC+CYC<br>Patients were treated with Glucocorticosteroid and Cyclophosphamide. | Drug: Cyclophosphamide<br>* Cyclophosphamide 1.0 intravenous every month.<br>Drug: GC<br>* Prednisone or equivalent 1 mg/kg/d(up to 60 mg), gradually tapering to 7.5mg/d in 24 weeks.<br>|
| Experimental: GC+T2<br>Patients were treated with Glucocorticosteroid and oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F). | Drug: Tripterygium wilfordii Hook F<br>* Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.<br>Drug: GC<br>* Prednisone or equivalent 1 mg/kg/d(up to 60 mg), gradually tapering to 7.5mg/d in 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Response | The proportion of patients achieving Complete Response (CR) and Partial Response(PR). | 24 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Function | The change in glomerular filtration rate(GFR) from baseline to week 24. | 24 weeks | 
| Serum Albumin Level | The change in serum albumin level from baseline to week 24. | 24 weeks | 
| Complement | The change in complement components from baseline to week 24, including: CH50(total complement activity), C3 and C4 level measured by nephelometry. | 24 weeks | 
| Anti-dsDNA | The change in anti-dsDNA antibody titers from baseline to week 24. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus Nephritis, Cyclophosphamide, Tripterygium