NCT01200784已完成2 期
Dose Finding Study of Nicotinamide in Hemodialysis Patients With Hyperphosphatemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 252
- 主要终点
- serum phosphate
研究概览
简要总结
Study hypothesis: Nicotinamide inhibits gastrointestinal phosphate absorption and serum phosphate levels of dialysis patients in a dose dependent manner.
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
- Double (Participant, Investigator)
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
- •hemodialysis since 3 months or longer
- •hemodialysis frequency 3 times weekly
- •stable phosphate binder dose since one month at screening
- •serum phosphate level < 2,42 mmol/l at screening
- •serum phosphate level > 1,52 mmol/l after wash out phase
- •stable treatment with vitamin D analogues since one month at screening
排除标准
- •congestive heart failure
- •acute bleeding complications
- •acute myocardial infarction
- •peptic ulcers
- •serious liver damage
- •poorly controlled diabetes
- •severe visual impairment
- •uncontrolled high blood pressure
- •thrombocyte count < 120/nl
- •difficulties in swallowing or dysphagia
- •diminished intestinal motility, megacolon, pseudo- or mechanical obstruction
- •gastroparesis
研究组 & 干预措施
250 mg/d modified release Nicotinamide
Experimental
干预措施: Nicotinamide (Drug)
500 mg/d modified release Nicotinamide
Experimental
干预措施: Nicotinamide (Drug)
750 mg/d modified release Nicotinamide
Experimental
干预措施: Nicotinamide (Drug)
1000 mg/d modified release Nicotinamide
Experimental
干预措施: Nicotinamide (Drug)
1000 mg/d immidiate release Nicotinamide
Active Comparator
干预措施: Nicotinamide (Drug)
结局指标
主要结局
serum phosphate
时间窗: 4 weeks of active treatment
次要结局
- serum phosphate(8 weeks of active treatment)
- serum calcium(4 and 8 weeks of acitve treatment)
- serum PTH(4 and 8 weeks of active treatment)
- adverse events(12 weeks)
研究者
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