NCT03596749Unknown3 期
The Effect of Sevelamer Carbonate on Serum Trimethylamine-n-Oxide (TMAO) Level in Patients With Chronic Kidney Disease (CKD) Stage 3b-4: a Protocol of a Randomized, Parallel, Controlled Trial
Fan Fan Hou1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Difference in the serum concentration of TMAO between treatment group and control group
研究概览
简要总结
The aim of this study is to investigate effects of sevelamer carbonate on reducing TMAO in stage 3b-4 CKD (pre-dialysis) patients. The study will also investigate the safety and tolerability of sevelamer carbonate in study population and the effects of sevelamer carbonate on serum p-cresyl sulfate, indoxyl sulfate, LDL-C and uric acid.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, aged from 18 to 75 years old;
- •Provide informed consent prior to enrolling in the study;
- •Estimated glomerular filtration rate (eGFR) between 15-45 ml/min/1.73 m2 (calculated by CKD-EPI equation)
排除标准
- •Documented poorly controlled diabetes mellitus, poorly controlled hypertension, malignant tumour, or any clinically significant unstable medical condition;
- •Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation;
- •Known hypersensitivity to sevelamer or any constituents of the study drug;
- •Unable to comply with the requirements of the study;
- •Hypophosphatemia (serum phosphorus level <0.87mmol/L);
- •Women who have a positive pregnancy test at enrollment or women who are breast-feeding;
- •Have been enrolled in other interventional study;
- •Received sevelamer or other intestinal adsorbents, or broad-spectrum antibiotic within one month prior to the screening period.
研究组 & 干预措施
Sevelamer Carbonate
Experimental
Sevelamer carbonate will be given with fixed dose of 1600mg (p.o. b.i.d) with meals
干预措施: Sevelamer Carbonate (Drug)
结局指标
主要结局
Difference in the serum concentration of TMAO between treatment group and control group
时间窗: 22 weeks
The serum concentration of TMAO will be evaluated by high performance liquid chromatography (HPLC)
次要结局
- Difference in the serum concentration of indoxyl sulfate between treatment group and control group(22 weeks)
- Difference in the serum concentration of p-cresyl sulfate between treatment group and control group(22 weeks)
- Difference in the serum concentration of LDL-C between treatment group and control group(22 weeks)
- Difference in the serum concentration of uric acid between treatment group and control group(22 weeks)
研究者
Fan Fan Hou
Chief of Division of Nephrology
Nanfang Hospital, Southern Medical University
研究点 (1)
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