EUCTR2006-003364-64-FI进行中（未招募）不适用
A phase IV, open-label, multi-centre trial evaluating the conversion from standard phosphate binder therapy to Fosrenol in chronic kidney disease stage 5 patients on haemodialysis
Shire Development Inc0 个研究点目标入组 760 人开始时间: 2007年9月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 760
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Aged 18 or over and receiving stable regimen of haemodialysis (two or three times a week for at least two months prior to screening) for CKD (stage 5) .
- •Females must be non-pregnant and non-lactating.
- •On a stable phosphate binder dose (no change in medication or dose for at least one month prior to screening) with screening serum phosphorus levels of between 1.78-2.43mmol/L.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with a corrected serum calcium level <2.1mmol/L (8.5mg/dL).
- •Subjects with an intact parapthyroid hormone level >500pg/ml or a history of parathyroidectomy within 12 months of screening.
- •Any significant GI disorders (including bowel obstruction, active, inflammatory bowel disease, GI motility disorders, abnormal or irregular bowel motion, major GI surgery in last 6 months.
- •Subjects receiving aluminium, magnesium, or combination therapy other than sevelamer HCl and calcium as a phosphate binder.
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