NCT00615173已完成3 期
Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in Lupus Nephritis
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Remission rate
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of tacrolimus vs intravenous cyclophosphamide pulses treatment for the induction therapy of LN(III,IV,V).
To compare the efficacy and safety of tacrolimus vs Azathioprine for the maintenance therapy of LN(III,IV,V).
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
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of either sex, 14-65 years of age;
- •Diagnosis of SLE according to the ACR criteria(1997);
- •Kidney biopsy within the 6 months prior to first randomization with a histologic diagnosis (ISN/RPS 2003 classification of LN) class III, IV, V;
- •Class IV LN: proteinuria >1g/24hr or Scr>115umol/L;
- •Class III or V LN: proteinuria >2g/24hr or Scr>115umol/L;
- •Provision of written informed consent by subject or guardian.
排除标准
- •Inability or unwillingness to provide written informed consent ;
- •Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide , azathioprine, corticosteroids;
- •Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
- •Pregnancy, nursing or use of a non-reliable method of contraception;
- •Continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;
- •Previous kidney transplant or planted transplant;
- •Scr > 4mg/dl (353umol/L);
- •Active hepatitis, with liver dysfunction;
- •Diagnosed DM;
- •Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .
研究组 & 干预措施
1
Experimental
tacrolimus(fk506) treatment in induction and maintenance phase
干预措施: tacrolimus (FK506) (Drug)
2
Active Comparator
intravenous cyclophosphamide pulses treatment in induction phase; and Aza in the maintenance phase
干预措施: cyclophosphamide or azathioprine (Drug)
结局指标
主要结局
Remission rate
时间窗: 2006-2008
次要结局
- Renal function, proteinuria, relapse.(2006-2008)
研究者
研究点 (1)
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