Effect of Lanthanum Carbonate and Sevelamer Hydrochloride on Gastrointestinal Calcium Absorption in Patients With Moderate to Advanced Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- the change of serum calcium for 24 hours after each drug
研究概览
简要总结
Sevelamer hydrochloride (SE) can increase intestinal calcium absorption in contrast to lanthanum carbonate (LA). Study compared effect of LA and SE on serum and urine phosphate and calcium, and hormones regulating mineral-bone metabolism.
详细描述
Recent experimental studies have shown that a non-calcium based phosphate binder sevelamer hydrochloride can increase intestinal calcium absorption in contrast to lanthanum carbonate. It is unknown whether such the difference may have an effect on bone metabolism and/or modify the development of vascular calcification in patients with chronic kidney disease. The aim of the study was to compare the effect of a single dose of 1000 mg of lanthanum carbonate with 2,4 mg of sevelamer hydrochloride on serum and urine calcium following an oral load of 5 g of calcium carbonate given with a meal with standardized phosphate content.
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
- None
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
- •adult patient
- •with eGFR ≤45 ml/min
排除标准
- •hypercalcemia (>ULN),
- •serum phosphate >1.2 times normal value
- •calcium-phosphate disturbances not associated with CKD, e.g. Paget disease, osteoporosis, any bone fracture within 6 months before study, multiple myeloma or any neoplastic disease, liver or biliary tract disease, primary hyperparathyroidism
研究组 & 干预措施
sevelamer hydrochloride
the subject receive a single dose of 2,4 g
干预措施: Sevelamer Hydrochloride (Drug)
sevelamer hydrochloride
the subject receive a single dose of 2,4 g
干预措施: Lanthanum Carbonate (Drug)
lanthanum carbonate
the subject receive a single dose of 1.0 g
干预措施: Sevelamer Hydrochloride (Drug)
lanthanum carbonate
the subject receive a single dose of 1.0 g
干预措施: Lanthanum Carbonate (Drug)
结局指标
主要结局
the change of serum calcium for 24 hours after each drug
时间窗: 3, 6, 12 and 24 hours after administration of each drug
absolute change vs baseline and 24h area under the curve
次要结局
未报告次要终点
研究者
Michal Nowicki
Prof
Medical University of Lodz