NCT00806481已完成2 期
Does Phosphate Binding With Sevelamer Carbonate Improve Cardiovascular Structure and Function in Patients With Early Chronic Kidney Disease?
University Hospital Birmingham NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in left ventricular mass
研究概览
简要总结
The purpose of this study is to determine whether lowering phosphate in patients with early chronic kidney disease with the phosphate binder sevelamer has beneficial effects on cardiovascular structure and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •Chronic kidney disease patients aged 18 to 80 years
- •Chronic kidney disease stage 3 (defined as a glomerular filtration rate of 30-60 ml/min/1.73m2)
- •Office blood pressure controlled to less than 140/90 mmHg for 12 months before entry into the study
- •Total cholesterol less than 5.5 mmol/l
排除标准
- •Existing or previous treatment within 1 year with a phosphate binder or vitamin D analogue
- •Uncontrolled hyperphosphataemia (serum phosphate >1.8 mmol/l)
- •Uncontrolled secondary hyperparathyroidism (PTH >80 pg/ml)
- •Diabetes mellitus
- •Pregnancy
- •Moderate-severe cardiac valvular disease
研究组 & 干预措施
1
Active Comparator
Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks
干预措施: Sevelamer carbonate (Drug)
2
Placebo Comparator
Treatment group: treatment with tablets of placebo three times daily for 36 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in left ventricular mass
时间窗: 36 weeks
次要结局
- Aortic compliance as measured by cardiac magnetic resonance imaging(36 weeks)
- Arterial stiffness as measured by pulse wave velocity and pulse wave analysis(36 weeks)
- Arterial elastance as measured by echocardiography(36 weeks)
- Left ventricular systolic and diastolic elastance measured by echocardiography(36 weeks)
- Bone density on dual-energy x-ray absorptiometry scanning(36 weeks)
研究者
Charles Ferro, Dr
Consultant Nephrologist and Honorary Senior Lecturer
University Hospital Birmingham NHS Foundation Trust
研究点 (1)
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