NCT01328834已完成3 期
Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Treatment in Refractory Lupus Nephritis
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)
研究概览
简要总结
This a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).
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 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 study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class IV, V, V+ III, V+ IV;
- •Usage of intravenous pulse cyclophosphamide for more than 3 times or immunosuppression therapy (AZA, MMF, oral cyclophosphamide, ect) for more than 6 months;
- •proteinuria > 1g/24hr or Scr > 1.3 mg/dl or active urinary sediment (erythrocyte cast, > 5 WBC/high power field (hpf) (excluding infection), > 5 RBC/hpf);
- •Provision of written informed consent by subject or guardian
排除标准
- •Inability or unwillingness to provide written informed consent ;
- •Usage of immunosuppression therapy (MMF, CTX, CysA, MTX etc) for more than 1 week within 1 month or intravenous MP Pulse treatment prior to entry;
- •Scr > 4mg/dl (354umol/L);
- •Needing pulse intravenous MP or intravenous immunoglobulin;
- •Lupus encephalopathy;
- •Diagnosed DM; Malignant tumors (except fully cured basal cell carcinoma);
- •History of significant gastrointestinal disorders (e.g. active peptic ulcer disease or pancreatitis) within 3 month prior to enter this study;
- •Known hypersensitivity or contraindication to tacrolimus, corticosteroids
- •Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C;
- •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.
研究组 & 干预措施
ADVAGRAF
Experimental
Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase
干预措施: Tacrolimus Sustained-release Capsules (ADVAGRAF) (Drug)
结局指标
主要结局
Remission rate (complete or partial remission)
时间窗: 6 months after therapy
次要结局
- The changes of proteinuria(every 3 months up to 6 months)
- SLEDAI scores(every 3 months up to 6 months)
- Number of participants with adverse events as a measure of safety and tolerability(every 3 months up to 6 months)
- The changes of renal function(every 3 months up to 6 months)
- Relapse(every 3 months up to 6 months)
研究者
研究点 (1)
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