NCT01039428已完成2 期
A Study of HS219 in Chronic Kidney Disease Patients on Hemodialysis With Hyperphosphatemia
KDL Inc.22 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2009年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 22
- 主要终点
- Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline
研究概览
简要总结
This was a study to evaluate the efficacy and safety of HS219, chitosan-loaded chewing gum, when given three times a day for 3 weeks to the hemodialysis (HD) patients with hyperphosphatemia whose serum inorganic phosphorus was not well controlled with calcium carbonate or sevelamer hydrogen chloride.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent given
- •Able to comply with the study procedures and medication
- •On a stable HD regimen (at least 3 x per week) for ≥ 3 months
- •Subject receiving calcium carbonate or sevelamer hydrochloride as a phosphate binder at screening, must have been on a stable regimen (dose and medication) for at least 1 month
- •A mean serum inorganic phosphorous in the previous 3 tests : > 5.5 mg/dL and < 9.0 mg/dL
- •Removal rate of blood urea nitrogen (BUN) ≥ 60%
- •Rate of salivary flow by Saxon test ≥ 1 g/2 min
排除标准
- •Blood purification therapy other than HD
- •Current clinically significant intestinal motility disorder
- •Possible parathyroid intervention during the study period
- •History of malignancy and severe cardiovascular disorders such as heart disease, angina, congested heart failure, valve stenosis, atrial fibrillation and arrhythmia
- •History of allergy against active ingredient
- •Receipt of any investigational drug within 30 days of informed consent
结局指标
主要结局
Change in Serum Inorganic Phosphorus at the End of Treatment From Baseline
时间窗: baseline and end of the chewing treatment during three week treatment period
Change in serum inorganic phosphorus at the end of treatment from baseline
次要结局
- Achievement Number of Participants With Serum Inorganic Phosphorus; 3.5 ≦P<5.5 mg/dL at Week 3(week 3)
- Number of Participants With Serum Inorganic Phosphorus Reduction of 1.5 mg/dL(baseline and end of the treatment)
- Salivary Inorganic Phosphorus Level(week 3)
- Ca×P(week 3)
- Serum Intact Fibroblast Growth Factor (FGF) 23 Level(week 3)
- Corrected Serum Calcium (Ca) Level Based on the Serum Albumin Level Corrected Serum Calcium (mg/dL) = Measured Total Ca (mg/dL) + (4 - Serum Albumin [g/dL])(week 3)
- Serum Intact Parathyroid Hormone (PTH) Level(week 3)
- Serum Inorganic Phosphorus Level(week 3)
研究者
研究点 (22)
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