NCT01451489终止不适用
A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis
Nanjing University School of Medicine1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2011年10月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- the rates of the complete remission during the induction phase
研究概览
简要总结
This is a prospective,multicentre study to compare the efficacy, safety, tolerability and relapse of FK506 versus CTX in the treatment of severe Focal Segmental Glomerulosclerosis (FSGS).
详细描述
- Using the response rate and completely response time to compare the efficacy of FK506 versus CTX therapy for the severe FSGS patients.
- To compare the safety and tolerability of FK506 versus CTX for the severe FSGS patients.
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
- •patients with a diagnosis of FSGS.
- •Patients with a proteinuria ≥ 3.5g/24h,and blood albumin <30g/L,and Scr< 2.3 mg/dl and eGFR>30ml/min per 1.73m
- •Patients who signed written informed consent form (patients less than 18 years old with their parents/legal representative's signatures), and have given their consent to follow all study procedures and follow-up.
排除标准
- •Patients who have received treatment of FK506 in latest 2 month or the cumulative dose CTX≥6 g.
- •Patients who are known to be allergic to a macrolide.
- •Patients who have active hepatitis.
- •Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit .
- •Patients with blood leukocyte < 3000/ul.
- •Patients with kidney disease family history
- •Patients with 2 type diabetes.
- •Patients with obesity whose BMI>28kg/m2.
研究组 & 干预措施
Cyclophosphamide
Active Comparator
CTX
干预措施: Cyclophosphamide (Drug)
FK506
Experimental
0.05-0.1mg/kg/d;adjust the dose according the serum concentration(aim 5-10ng/ml),maximum dose 6mg/day;divided in twice, interval 12 hours.
干预措施: FK506 (Drug)
结局指标
主要结局
the rates of the complete remission during the induction phase
时间窗: 6 months
次要结局
- the total remission rates(18 months)
研究者
Zhi-Hong Liu, M.D.
Professor
Nanjing University School of Medicine
研究点 (1)
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