NCT00324376已完成2 期
A Randomized, Cross-Over Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
Genzyme, a Sanofi Company2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2003年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Treatment compared on basis of serum phosphorus at end of each treatment and calcium corrected for albumin,calcium-phosphorus product,albumin,iPTH,total,LDL,HDL,non-HDL cholesterol,triglycerides. Safety evaluated on AEs;change in lab values.
研究概览
简要总结
A randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to one of the following treatment sequences:
- sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals
- sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal. Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening.
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
- •life expectancy of at least 12 months,
- •patients have received hemodialysis three times per week for 3 months or longer,
- •patients maintained on sevelamer in a daily dose of ≤ 9,600 mg as their only phosphate binder with serum phosphorus concentrations at the last two measurements between 3.0 and 6.5 mg/dL (0.97 and 2.10 mmol/L).
排除标准
- •active bowel obstruction,
- •dysphagia,
- •swallowing disorders,
- •severe gastrointestinal motility disorders,
- •active ethanol or drug abuse (excluding tobacco),
- •need for antidysrhythmic or antiseizure medications used to control these conditions,
- •poorly controlled diabetes mellitus or hypertension,
- •active vasculitis,
- •active malignancy other than basal-cell carcinoma,
- •HIV infection,
- •any clinically significant unstable medical condition as judged by the investigator.
结局指标
主要结局
Treatment compared on basis of serum phosphorus at end of each treatment and calcium corrected for albumin,calcium-phosphorus product,albumin,iPTH,total,LDL,HDL,non-HDL cholesterol,triglycerides. Safety evaluated on AEs;change in lab values.
次要结局
未报告次要终点
研究者
研究点 (2)
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