Impact of Kremezin on Renal Recovery and Uremic Toxin Levels in Patients With Acute Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in serum indoxyl sulfate (IS) concentration
研究概览
简要总结
The primary goal of this clinical trial is to evaluate the efficacy of AST-120 (Kremezin®) in combination with standard care in reducing the levels of protein-bound uremic toxins (PBUTs), specifically indoxyl sulfate (IS) and p-cresyl sulfate (p-CS), in patients with acute kidney disease (AKD). The trial aims to assess whether AST-120 can prevent further renal deterioration and slow the progression from AKD to chronic kidney disease (CKD) by mitigating the accumulation of PBUTs. Additionally, the study will investigate the potential of AST-120 to reduce the risk of CKD-associated complications, including cardiovascular disease, by reducing PBUT levels in AKD patients.
详细描述
Study Procedures：
- Total Number of Subjects The total number of subjects planned for enrollment is 100.
The study will include two groups:
- Experimental Group: 50 patients receiving AST-120 (6g/day) in combination with standard post-AKD care.
- Control Group: 50 patients receiving only standard post-AKD care. The sample size is determined based on the statistical power needed to detect a significant difference in the primary endpoint (percentage changes in IS levels), with consideration for potential dropout rates. The evaluable number is estimated to be close to 90, allowing for a 10% dropout rate, making the enrolled number 100.
2. Interventions, Procedures, and Tests for Each Group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental (AST-120 + Standard Care)
Intervention: AST-120 (Kremezin®) Dosage: 6 g/day (2 g TID, oral) Duration: 14 days Background treatment: Standard post-AKD care
干预措施: AST-120 (Kremezin®) (Drug)
结局指标
主要结局
Change in serum indoxyl sulfate (IS) concentration
时间窗: Day 0, Day 14, Day 90, Day 180
Change in serum indoxyl sulfate (IS) concentration Time Frame: Baseline to Day 180 Description: Evaluate reduction in IS levels after AST-120 treatment compared to control.
次要结局
- Change in serum p-cresyl sulfate (p-CS) concentration(Day 0, Day 14, Day 90, Day 180)
- Change in estimated glomerular filtration rate (eGFR)(Day 0, Day 14, Day 90, Day 180)
- Change in urine albumin/creatinine ratio (UACR)(Day 0, Day 14, Day 90, Day 180)
- Change in urine total protein/creatinine ratio (UPCR)(Day 0, Day 14, Day 90, Day 180)