To Investigate the Protective Effect of AC 134 in Chronic Kidney Diseases.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Uremic toxins assay
研究概览
简要总结
The objective is to explore the effects of adding AC-134 on renal function, proteinuria, uremic toxins, and metabolism-related markers in chronic kidney disease.
详细描述
Chronic kidney disease (CKD) management primarily focuses on addressing associated complications such as hypertension, diabetes mellitus, cardiovascular disease, and proteinuria. In addition to standard therapies, reducing the accumulation of toxins, particularly gut-derived uremic toxins like indoxyl sulfate (IS) and p-cresol sulfate (PCS), may help alleviate uremia symptoms. This study assesses the impact of oral AC-134 capsules containing activated charcoal adsorbent on CKD patients. The assessment will include evaluating changes in renal function, proteinuria, uremic toxins, and metabolism-related markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20-90 years.
- •Diagnosed with stage 3-5 chronic kidney disease, excluding dialysis patients.
- •Signed informed consent is required before enrollment.
排除标准
- •Use of other brand-activated charcoal supplements during the study period.
- •Pregnant or lactating women.
- •Patients who have undergone kidney transplantation.
- •Obstructive nephropathy within the past month.
- •Acute kidney injury within the past three months.
- •Gastrointestinal bleeding or severe constipation within the past three months.
- •Patients with active malignancy within the past two years.
- •Severe cardiovascular diseases such as congestive heart failure New York class III-IV or cerebrovascular disease
- •Severe liver disease, such as liver cirrhosis with ascites.
- •Active infectious disease
研究组 & 干预措施
Intervention group
Low-protein diet strategies combined with AC-134 capsules
干预措施: Low protein diet with AC-134 (Dietary Supplement)
Control group
Low-protein diet strategies
干预措施: Standard treatment (Other)
结局指标
主要结局
Uremic toxins assay
时间窗: Baseline to 3 months
The concentration of p-cresol sulfate level, indoxyl sulfates level, and acrolein in the subjects' blood samples
Estimated glomerular filtration rate (eGFR) measurement
时间窗: Baseline to 3 months
The eGFR level is a maker for kidney function
Blood Urea Nitrogen (BUN) levels
时间窗: Baseline to 3 months
Blood Urea Nitrogen
次要结局
- Nutrition status(Baseline to 3 months)
- Lipid analysis(Baseline to 3 months)
- Liver function(Baseline to 3 months)
- The quality of life(Baseline to 3 months)
- Urine protein analysis(Baseline to 3 months)
- 24-hour Dietary recall(Baseline to 3 months)
- Gastrointestinal symptoms measures(Baseline to 3 months)
- Electrolytes Analysis(Baseline to 3 months)
- Inflammation makers(Baseline to 3 months)
- Sugar test(Baseline to 3 months)
- Anemia test(Baseline to 3 months)
- Grip strength levels(Baseline to 3 months)
- Blood gas(Baseline to 3 months)
- Mitochondrial oxidative stress(Baseline to 3 months)
研究者
Cheng-Hsu Chen
Professor, Division Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
Taichung Veterans General Hospital