Effect of Sevelamer on P-cresol Levels in CKD
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Effect on p-creol levels
研究概览
简要总结
The accumulation of p-cresol, a product of the metabolism of aromatic aminoacid operated by resident intestinal bacteria increases the cardiovascular risk of chronic kidney disease (CKD) patients. Therefore, therapeutic strategies to reduce plasma p-cresol levels are highly demanded. It has been reported that the phosphate binder sevelamer sequesters p-cresol in vitro, while in vivo studies on dialysis patients showed controversial results. Aim of our study was to evaluate the effect of sevelamer on p-cresol levels in 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years,
- •CKD stage 3-5
排除标准
- •Existing or previous treatment within the last 1 year with a phosphate binder;
- •hyperphosphatemia (>5.6 mg/dL);
- •hypophosphatemia (<2.5 mg/dL);
- •malnutrition,
- •malignant neoplasms,
- •current history of gastrointestinal and/or endocrine diseases.
研究组 & 干预措施
Sevelamer
The dose of Sev was 2400 mg (800 mg three times a day) in all patients.
干预措施: Sevelamer (Drug)
Placebo
The patients received placebo three times a day
干预措施: Placebo (Drug)
结局指标
主要结局
Effect on p-creol levels
时间窗: 3 months
The p-cresol levels will be evaluated in plasma samples withdrawn after 1, 2 and 3 months of therapy.
次要结局
未报告次要终点
研究者
Eleonora Riccio
MD
Federico II University