NCT04585607已完成4 期
Long-term Effects of Expanded Hemodialysis in Reduction of Large Middle Molecules in Chronic Hemodialysis Patients: Potential Benefits to the Prevention of Sarcopenia
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Biomarkers of sarcopenia
研究概览
简要总结
The current study will investigate whether long term implementation of expanded hemodialysis (HDx) will effectively decrease serum levels of large uremic toxins and ameliorate progression of sarcopenia in patients with chronic kidney disease requiring hemodialysis.
详细描述
This is an open-label, prospective, 1:1 randomized, parallel-group, study to evaluate the efficacy of expanded hemodialysis (HDx) compared to conventional hemodialysis in patients with chronic kidney disease in South Korea for up to 12 months.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •On HD treatment over 6 months before study enrollment
- •Aged over 18 years
- •Able to give informed consent
排除标准
- •Hemiplegia or paraplegia state
- •Planned renal transplant or conversion to peritoneal dialysis within study period
- •Active chronic infection or inflammatory conditions including autoimmune disease, inflammatory arthritis and active malignancy
- •History of monoclonal gammopathy
- •Life expectancy <12 months
- •Pregnancy or breast feeding
- •Receiving immunosuppressant medication
- •Inability to complete study assessments
结局指标
主要结局
Biomarkers of sarcopenia
时间窗: Changes in serum level of Myostatin and IGF-1 every 6 months
Change in blood levels of myostatin and insulin-like growth factor-1 (IGF-1)
次要结局
未报告次要终点
研究者
Hyeongcheon Park
Professor
Gangnam Severance Hospital
研究点 (1)
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