NCT02237534Unknown4 期
Lanthanum Carbonate Versus Calcium Carbonate for Vascular Abnormalities in Patients With Chronic Kidney Disease and Hyperphosphatemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Coronary artery calcification score
研究概览
简要总结
The purpose of this study is to compare the effect of lanthanum carbonate and calcium carbonate on the progression of coronary calcification and vascular endothelial dysfunction.
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
- 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
- •Hyperphosphatemia (For patients without calcium carbonate, ≥4.5 mg/dL) (For patients with calcium carbonate, ≥4.0 mg/dL)
- •With written informed consent
排除标准
- •History of cardiac surgery
- •With coronary artery stent
- •Polycystic kidney disease
- •Hypothyroidism
- •On treatment with lanthanum carbonate
- •History of admission within 3 months
- •History of ileus
- •Severe liver dysfunction
- •Severe gastrointestinal dysfunction
- •Allergy to lanthanum carbonate or calcium carbonate
- •Pregnant or breastfeeding women
- •Judged as ineligible by the investigator
研究组 & 干预措施
Calcium carbonate
Active Comparator
Start at a dose of 1,500 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 3,000 mg/day.
干预措施: Calcium Carbonate (Drug)
Lanthanum carbonate
Experimental
Start at a dose of 750 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 1,500 mg/day. For patients with calcium carbonate at inclusion, calcium carbonate will be replaced with lanthanum carbonate of 750 mg/day.
干预措施: Lanthanum carbonate (Drug)
结局指标
主要结局
Coronary artery calcification score
时间窗: 1 year
次要结局
- Serum bone metabolic markers(1 year)
- Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time(Up to 1 year)
- Estimated glomerular filtration rate over time(Up to 1 year)
- Bone mineral density(1 year)
- Cardiovascular event requiring hospitalization(Up to 1 year)
- Death(Up to 1 year)
- Endothelial function(3 months)
- Urinary alpha-Klotho to creatinine ratio(1 year)
- End-stage renal disease requiring renal replacement therapy(Up to 1 year)
- Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio(1 year)
- Serum osteoprotegerin concentration(1 year)
研究者
Takayuki Hamano
Endowed chair
Osaka University
研究点 (1)
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