Tacrolimus Treatment of Patients With Idiopathic Focal Segmental
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis
研究概览
简要总结
The purpose of this study is to assess the efficacy of Tacrolimus Treatment of patients with idiopathic focal segmental glomerulosclerosis.
详细描述
Primary FSGS is a leading cause of end stage renal disease in adults, with complete loss of kidney function in 50% of patients over 10 years. Steroids, which are currently used to treat the disease, are effective in part of patients. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with Cyclosporine-A (CSA) in patients with FSGS. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cells, for example, tacrolimus, may be effective in the treatment of primary FSGS. The experience with Tacrolimus (FK506) in the treatment of patients with FSGS has been limited to uncontrolled trials in adult patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 14-50 years at onset of signs or symptoms of FSGS
- •Biopsy proven FSGS
- •Estimated glomerular filtration rate (GFR) ≥ 40 ml/min/1.73 m2
- •Urine protein > 3.5 g/24h
- •Biopsy confirmed primary FSGS (including all subtypes)
- •Willingness to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures
排除标准
- •Secondary FSGS
- •Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil levamisole, methotrexate, or nitrogen mustard in the last 90 days
- •Active/serious infection
- •Malignancy
- •Previously diagnosed diabetes mellitus type 1 or 2
- •Clinical evidence of cirrhosis or chronic active liver disease
- •History of significant gastrointestinal disorder
- •Allergy to study medications, and Inability to consent/assent
研究组 & 干预措施
Tacrolimus
干预措施: Tacrolimus (Drug)
结局指标
主要结局
To assess the efficacy of Tacrolimus Treatment Idiopathic Focal Segmental Glomerulosclerosis
时间窗: 18 months
次要结局
- To investigate the safety and tolerability of Tacrolimus vs Steroids in Treatment Idiopathic Focal Segmental Glomerulosclerosis(18 months)