Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate on Cardiovascular Mortality and Morbidity in Patients With Chronic Kidney Disease on Hemodialysis (CKD5D)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,309
- 试验地点
- 1
- 主要终点
- Cardiovascular event free survival time.
研究概览
简要总结
The purpose of this study is to demonstrate decrease in cardiovascular mortality and morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with those with Calcium carbonate.
详细描述
Elevated serum phosphate and calcium in dialysis patients are independently associated with increased risk of arterial calcification and mortality. Calcium-based phosphate binders can induce hypercalcaemia and are associated with progression of vascular calcification. A recent randomized study demonstrated that sevelamer, a non-calcium-based phosphate binders, reduced mortality in elderly hemodialysis patients compared with calcium-based phosphate binders. Lanthanum carbonate is another efficacious and well-tolerated non-calcium phosphate binder. A post-hoc survival analysis of lanthanum carbonate versus standard therapy suggested a survival benefit of lanthanum carbonate treatment for elderly patients.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemodialysis patients with hyperphosphatemia who require phosphate binders
- •hemodialysis for more than 3 months
- •patients who have at least one calcification risk factor (elderly > 65 years, postmenopausal woman, type 2 diabetes mellitus)
- •intact-PTH < or = 240pg/mL
- •life expectancy > 1 year
- •with written informed consent
排除标准
- •contraindications to lanthanum carbonate and calcium carbonate
- •swallowing disorders
- •severe GI disorders
- •history of obstructed bowels
- •history of IHD/stroke within 6 months before randomization
- •NYHA classification Ⅲ-Ⅳ
- •severe liver dysfunction (AST or ALT greater than 3 times the upper limit of institution
- •require treatment of arrhythmia
- •severe malnutrition
- •malignancy of any type within the last five years
- •peritoneal dialysis patients
- •pregnant or possibly pregnant women or women on lactation and planned to get pregnant within study term
- •ineligible patients according to the investigator's judgment
研究组 & 干预措施
Lanthanum carbonate
Patients are given Lanthanum Carbonate oral administration after meals three times per day in total daily dose of 750-2250mg.
干预措施: Lanthanum Carbonate (Drug)
Calcium Carbonate
Patients are given Calcium carbonate oral administration after meals three times per day in total daily dose of 3.0g.
干预措施: Calcium Carbonate (Drug)
结局指标
主要结局
Cardiovascular event free survival time.
时间窗: 3 years
Cardiovascular event consisting of 1. death due to cardiovascular diseases including sudden cardiac death (ICD-10 codes R96.0/96.1), 2. nonfatal myocardial infarction, 3. nonfatal cerebral stroke including transient ischemic attack, TIA, 4. unstable angina, 5. hospitalization for heart failure, 6. hospitalization for ventricular arrhythmia
次要结局
- Overall survival(3 years)
- Quality of life questionnaire (KDQOL-SF, v1.3)(3 years)
- Hip fracture free survival(3 years)
- Bone mineral density (DEXA)(3 years)
- Secondary hyperparathyroidism free survival(3 years)