Effect of An Oral Absorbent AST-120 in Late-stage Chronic Kidney Disease (CKD) Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- renal function change
研究概览
简要总结
Recent research work has directed especial attention toward a distinct group of uremic retension molecules, called "protein-bound uremic toxins". The prototypes of this group of uremic toxins are indoxyl sulfate and p-cresol. These uremic toxins can promote production of free radical and impair antioxidant system and exerts direct toxicity on different cells and organs, including mesangial, tubular, endothelial cell and osteoblasts. Accumulation of these protein bound uremic toxins results in glomerular sclerosis and interstitial fibrosis of kidneys of uremic rats and confer skeletal resistance to parthyroid hormone in uremic patients. In hemodialysis, high serum p-cresol level is associated with higher cardiovascular mortality.
AST-120 (Kremezin) is a carbonated oral absorbent extensively used in Japan and Korea. It has superior adsorption ability for certain small-molecular weight organic compounds known to accumulate in patients with CKD. In uremic rats and CKD patients, oral administration of AST-120 decreased the elevated pretreatment levels of serum indoxyl sulfate. In Japan, it was reported that AST-120 suppressed the increase in serum creatinine levels, prevented proteinuria, improved uremic symptoms, and, consequently, led to the postponement of dialysis therapy.
Value of AST-120 on the outcome of late-stage CKD patients is still unknown. We hypothesized AST-120 through reduction of level of indoxyl sulfate and p-cresol can improved the morbidity- mortality of CKD patients.
The principal aim of this prospective cohort study is to investigate the effectiveness of AST-120 in incidence of dialysis and mortality of late-stage CKD patients. Determination of this relationship can help to establish new therapeutic strategy in the treatment of late-stage CKD patients.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged > 18 year-old or < 85 year-old
- •eGFR or CCR < 60 ml/min
- •hemoglobin < 10 g/dL, ESA-naïve, had adequate iron storage (serum ferritin > 200 ng/dL and transferrin saturation > 20%)
- •no spontaneous renal improvement or progression in past 3 months.
排除标准
- •renal transplant recipients, liver cirrhosis, bone marrow disorder
- •blood pressure > 170/80 mmHg in 3 occasions
- •recent cardiovascular disease (Coronary artery disease, myocardial ischemia, cerebrovascular disease or peripheral artery disease) or gastrointestinal bleeding in past 3 months
- •acute tubular necrosis in the past 3 months
- •unwilling to participate in the trial
研究组 & 干预措施
AST-120 group
Administration of AST-120
干预措施: AST-120 (Drug)
结局指标
主要结局
renal function change
时间窗: 1 year
次要结局
- anemia(1 year)
研究者
iwenwu
Attending Physician
Chang Gung Memorial Hospital
