NCT01845090Unknown4 期
Compared the Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 With Calcium Carbonate in Hemodialysis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- serum level of fibroblast growth factor
研究概览
简要总结
To compare the effect of lanthanum carbonate with calcium carbonate on serum FGF23 levels in hemodialysis patients.
详细描述
The investigators enrolled patients on maintenance hemodialysis and randomized them to two groups. One group will receive lanthanum carbonate and another group will receive calcium carbonate. The investigators will compare serum FGF23 levels between two groups after they receive above medication for 6 months.
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
- Single (Outcomes Assessor)
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
- •Age > 18 years old
- •Chronic renal failure on maintenance hemodialysis 3 times a week for at least 3 months Serum calcium:8-10.5 mg/dL
- •Serum phosphate:3.5-6 mg/dL(before washout period)
- •Serum phosphate ≧6 mg/dL after washout period
- •Serum i-PTH: 150-600 pg/mL
排除标准
- •Diabetes mellitus
- •Post parathyroidectomy
- •Life expectancy< 6 months
- •Liver disease(hepatitis B,C or liver dysfunction)
- •Severe gastrointestinal disorders or other severe comorbidity
- •Poor compliance
- •Intolerance to lanthanum or calcium carbonate
- •Active infection
- •Malnutrition(serum albumin<3 g/dL or clinical assessment)
- •Kt/V< 1.2 (inadequate dialysis)
- •Serum phosphate>7.5 mg/dL after washout period
研究组 & 干预措施
Lanthanum carbonate
Active Comparator
Lanthanum carbonate 375mg~750 mg tid for 6 months
干预措施: Lanthanum carbonate (Drug)
Calcium carbonate
Active Comparator
Calcium carbonate 500mg~1000 mg tid for 6 months
干预措施: Calcium Carbonate (Drug)
结局指标
主要结局
serum level of fibroblast growth factor
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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