NCT00615667已完成3 期
Prospective, Multicenter Study of the Efficacy and Tolerance of Tacrolimus on Refractory Nephrotic Syndrome (RNS)
Sun Yat-sen University0 个研究点目标入组 61 人开始时间: 2006年6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
- 61
- 主要终点
- Remission rate
研究概览
简要总结
Exploring the efficacy and safety of Tacrolimus on refractory nephrotic syndrome ; Acquiring the experience of Tacrolimus on the treatment of refractory nephrotic syndrome in Chinese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 Nephrotic syndrome with hypoalbuminemia (<3.0g/dl) and heavy proteinuria (> 3.5g/24hr);
- •Provision of written informed consent by subject or guardian;
- •Refractory nephrotic syndrome:
- •Steroid resistant: Persistence of proteinuria despite prednisone therapy 1mg/kg/d for 16 weeks; Steroid dependent: NS recurs when steroid dosage decease.Twice within 6 months, and 3 times within 1 year.
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
tacrolimus(fk506) treatment
Experimental
tacrolimus(fk506) treatment
干预措施: tacrolimus (FK506) (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
Xue Qing Yu
Professor
Sun Yat-sen University
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