Tacrolimus Treatment of Patients With Idiopathic
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
- 是
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
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
Zhi-Hong Liu, M.D.
Research Institute of Nephrology
Nanjing University School of Medicine
