Effect of Galactose on Permeability Factor in Patients With Focal Segmental Glomerulosclerosis (FSGS)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 主要终点
- Reduction in FSGS permeability factor
研究概览
简要总结
This study is a proof-of-concept clinical study designed to test the hypothesis that oral administration of galactose can lower the level of a circulating factor that increases glomerular permeability to albumin in patients with resistant FSGS.
详细描述
Patients with resistant FSGS have persistent proteinuria and a high risk of progression to end stage kidney disease (ESKD). A circulating factor that increases glomerular permeability to albumin (Palb) has been detected in over 50% of these patients. While the molecular identity of the factor has not been fully established, in vitro studies and limited clinical experience suggest that galactose can reduce the level of the FSGS permeability factor.
This study is a pilot study to determine if oral administration of galactose can lower the circulating level of the FSGS permeability factor.
Two groups of patients with biopsy proven primary FSGS who are resistant to steroids and one other immunosuppressive agents will be studied:
l. FSGS, pre-ESKD 2. FSGS, with ESKD on renal replacement therapy
The only eligibility factor is presence of the FSGS permeability factor.
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
- 2 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary FSGS
- •Resistance to steroids and another immunosuppressive medication
排除标准
- •Secondary FSGS
研究组 & 干预措施
1
Galactose
干预措施: Galactose (Drug)
结局指标
主要结局
Reduction in FSGS permeability factor
时间窗: 28 days
次要结局
未报告次要终点
研究者
Howard Trachtman MD
principal investigator
Northwell Health