EUCTR2006-003364-64-FR进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 one month for at least one month prior to screening) with screening serum phosphorus levels of between 5.6 and 7.5 mg/dL inclusive.
- •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.
研究者
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