NCT01755078已完成4 期
Long Term Evaluation of Sevelamer HCl vs. Calcium-based Phosphate Binder in the Treatment of Hyperphosphatemia in Hemodialysis Patients
Chugai Pharma Taiwan0 个研究点目标入组 166 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 主要终点
- Composite end-point of Ca, P, Ca*P within K/DOQI recommendation
研究概览
简要总结
The study is designed to compare sevelamer vs. calcium-based phosphate binder in hemodialysis patients to achieve full-scale of medical care, including reduction of atherosclerotic risk factors, reduction of vascular access reconstruction rate, and pharmacoeconomic analysis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged between 18-70 years old
- •Subject with hyperphosphatemia (5.5 - 8.5 mg/dL) at both WK(-2) and WK0
- •On stable TIW hemodialysis for 3 months or longer
排除标准
- •Patients with hypercalcemia (corrected serum calcium > 10.5 mg/dL)
- •Any of the following abnormalities: ALT or AST > 3X ULN; iPTH > 1000 or < 150 pg/mL
- •History of dysphagia or swallowing disorders
- •History of GI motility disorder or GI bleeding within 3 months prior to entry
研究组 & 干预措施
Sevelamer HCl
Experimental
Sevelamer HCl regular treatment 1-3 tablets TID
干预措施: Sevelamer HCl (Drug)
Calcium-based binder
Active Comparator
Calcium-based phosphate binder (either CaCO3 or Ca acetate) administered 1-3 tablets TID
干预措施: Calcium-based phosphate binder (Drug)
结局指标
主要结局
Composite end-point of Ca, P, Ca*P within K/DOQI recommendation
时间窗: 12 months
次要结局
- CV-related event rate (OPD admission and hospitalization)(12 months)
- Change from baseline, lipid profile(12 months)
- Change from baseline, iPTH (stragified)(12 months)
- Change from baseline, CRP(12 months)
- Change from baseline, homocysteine, folate and Vit B12(12 months)
- Comparison of medical-related expenses between group(12 months)
- Change from baseline, Ca, P, Ca*P(12 months)
研究者
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