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.
试验速览
- 阶段
- 2 期
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Renal Response
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 T
- •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
研究组 & 干预措施
GC+CYC
Patients were treated with Glucocorticosteroid and Cyclophosphamide.
干预措施: Cyclophosphamide (Drug)
GC+CYC
Patients were treated with Glucocorticosteroid and Cyclophosphamide.
干预措施: GC (Drug)
GC+T2
Patients were treated with Glucocorticosteroid and oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).
干预措施: Tripterygium wilfordii Hook F (Drug)
GC+T2
Patients were treated with Glucocorticosteroid and oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).
干预措施: GC (Drug)
结局指标
主要结局
Renal Response
时间窗: 24 weeks.
The proportion of patients achieving Complete Response (CR) and Partial Response(PR).
次要结局
- Renal Function(24 weeks)
- Serum Albumin Level(24 weeks)
- Complement(24 weeks)
- Anti-dsDNA(24 weeks)
研究者
Fengchun Zhang
Professor
Peking Union Medical College Hospital