The Efficacy and Safety of Nicotinic Acid in the Hemodialysis Patients With Hyperphosphatemia
试验速览
- 阶段
- 4 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- change in serum phosphorus
研究概览
简要总结
With calcium carbonate as the positive control drug, to observe the effectiveness and safety of nicotinic acid in hemodialysis patients with hyperphosphatemia
详细描述
Hyperphosphatemia is an important risk factor affecting long-term survival in patients with hemodialysis. Nicotinic acids, as well as its metabolites nicotinamide, were found to inhibit the sodium-phosphorus co-transporter on animal intestines. Several studies from other countries demonstrated that nicotinamide can reduce blood phosphorus levels in end-stage kidney disease patients. The purpose of this study was to investigate the effectiveness and safety of nicotinic acids on hyperphosphatemia in hemodialysis patients of ethnic Han live in China. The study is a prospective, randomized, double-blind, placebo-controlled crossover study. Eligible patients will be randomized to 6 wk of nicotinic acids or calcium carbonate. After a 2-wk washout period, patients switched to 6 wk of the alternative therapy. The primary measurement is the change in serum phosphorus during the whole term of each arm. Statistical analysis will be performed using two-sample paired-group t test.The significance level of the analysis was set to 0.05. All other adverse reactions will be analysed and reported, if there.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •ethnic Han live in China, End-stage renal disease（ESRD）patients treated with hemodialysis ≥ 3 months, between 18 and 80 years of age, serum phosphorus > 1.78 mmol/L, capable of giving informed consent
排除标准
- •Be allergic to nicotinic acids, dysphagia, pregnant, current medication regimen including niacin or niacinamide active liver disease, peptic ulcer disease, full resection of parathyroid, malignancy, quit hemodialysis
研究组 & 干预措施
control group
Group treated with calcium carbonate for 6 weeks first,then switch to nicotinic acids treatment after 2 week of wash-out.
干预措施: Calcium Carbonate (Drug)
nicotinic acids group
Group treated with nicotinic acids for 6 weeks first,then switch to calcium carbonate treatment after 2 week of wash-out.
干预措施: Nicotinic Acids (Drug)
结局指标
主要结局
change in serum phosphorus
时间窗: Immediately after wash-out period and after 6 weeks of therapy.
次要结局
- change in serum calcium(Immediately after wash-out period and after 6 weeks of therapy.)
- change in serum calcium-phosphorus product(Immediately after wash-out period and after 6 weeks of therapy.)
- change in intact parathyroid hormone(Immediately after wash-out period and after 6 weeks of therapy.)
- change in alkaline phosphatase(Immediately after wash-out period and after 6 weeks of therapy.)
- change in platelet count(Immediately after wash-out period and after 6 weeks of therapy.)
- change in serum uric acid(Immediately after wash-out period and after 6 weeks of therapy.)
- change in serum glucose(Immediately after wash-out period and after 6 weeks of therapy.)
- change in total cholesterol(Immediately after wash-out period and after 6 weeks of therapy.)
- change in triglyceride(Immediately after wash-out period and after 6 weeks of therapy.)
- change in high density lipoprotein cholesterol(Immediately after wash-out period and after 6 weeks of therapy.)
- change in low density lipoprotein cholesterol(Immediately after wash-out period and after 6 weeks of therapy.)
- change in serum glutamic-pyruvic transaminase(Immediately after wash-out period and after 6 weeks of therapy.)
- change in glutamic oxalacetic transaminase(Immediately after wash-out period and after 6 weeks of therapy.)
- change in bilirubin(Immediately after wash-out period and after 6 weeks of therapy.)
研究者
Xiaoran Feng
deputy director of nephrology division
Jiujiang No.1 People's Hospital