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临床试验/NCT00302523
NCT00302523已完成不适用

Tacrolimus Treatment of Patients With Idiopathic

Nanjing University School of Medicine2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
To explore the potential role of tacrolimus in the treatment of membranous nephropathy.

研究概览

简要总结

The purpose of this study is:

  • To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
  • To investigate the safety and tolerability of tacrolimus vs methylprednisolone plus cyclophosphamide.

详细描述

Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with Cyclosporine-A (CSA) in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a new calcineurin immunosuppressive drug, tacrolimus (FK506), in reducing the amount of protein in the urine in patients with membranous nephropathy. Forty patients with biopsy-proven membranous nephropathy will be recruited. Candidates must have completed at least six month of treatment with a stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy. They will be treated with oral tacrolimus for 6 months, followed by 6 months of maintenance. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day. This study will explore the potential role of tacrolimus in the treatment of membranous nephropathy, which is usually resistant to conventional therapy.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Biopsy-proven idiopathic membranous nephropathy
  • Nephrotic syndrome with proteinuria ( > 4 g/day) and serum albumin < 30 g/dl
  • Age 18-60 years with informed consent

排除标准

  • Patient with abnormal liver function tests
  • Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
  • Active/serious infection
  • Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
  • Patient who is diabetic
  • Patient is allergic or intolerant to macrolide antibiotics or tacrolimus

研究组 & 干预措施

FK506

Active Comparator

干预措施: Tacrolimus (Drug)

结局指标

主要结局

To explore the potential role of tacrolimus in the treatment of membranous nephropathy.

时间窗: 18 months

次要结局

  • To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse.(18 months)

研究者

发起方
Nanjing University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhi-Hong Liu, M.D.

Research Institute of Nephrology

Nanjing University School of Medicine

研究点 (2)

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