NCT01309477已完成3 期
The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS)
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年1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
- 20
- 试验地点
- 1
- 主要终点
- Remission rate (complete or partial remission) at 6 months
研究概览
简要总结
It is a pilot study to explore the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) on 6-month induction therapy of Refractory Nephrotic Syndrome (RNS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of either sex, 14-60 years of age
- •Diagnosis of Nephrotic syndrome with hypoalbuminemia (< 3.0g/dl) and heavy proteinuria (> 3.5g/24hr) and exclude secondary Nephrotic syndrome
- •Refractory Nephrotic Syndrome
- •Steroid resistant: failure to respond (either complete or partial remission) after a course of 8 weeks of 1.0 mg/kg/d prednisone or equal dose of steroid therapy
- •Steroid dependent: recurrence of nephrotic proteinuria during tapering of prednisone at a dose > 10 mg/day or within the first 2 weeks after withdrawal of prednisone
- •Frequently recurrence: initial remission with steroid induction therapy, but relapsed 2 or more in 6 months or 3 or more within 12 months
- •Failure to respond (either complete or partial remission) even after CTX, MMF or CsA therapy combined with steroid
- •eGFR ≥ 60 ml/min/1.73 m2
- •Provision of written informed consent by subject or guardian
排除标准
- •Systemic disease
- •eGFR < 60ml/min/1.73m2
- •Diagnosed DM
- •Malignant tumors (except fully cured basal cell carcinoma)
- •Familial nephritic syndrome
- •History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study
- •Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C
- •Known hypersensitivity or contraindication to tacrolimus, corticosteroids
- •Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening
- •Pregnancy, nursing or use of a non-reliable method of contraception
- •Inability or unwillingness to provide written informed consent
- •Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization or intravenous MP Pulse treatment
研究组 & 干预措施
ADVAGRAF
Experimental
All subjects in the study will take the Tacrolimus Sustained-release Capsules (ADVAGRAF) orally at the basis of low dose prednisone treatment
干预措施: Tacrolimus Sustained-release Capsules (ADVAGRAF) (Drug)
结局指标
主要结局
Remission rate (complete or partial remission) at 6 months
时间窗: 6 months after therapy
次要结局
- relapse rate(every 3 months up to 6 months)
- side effects(every 3 months up to 6 months)
研究者
研究点 (1)
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