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临床试验/NCT01903213
NCT01903213已完成不适用

Post-Marketing Surveillance on Long-Term Drug Use of Kiklin (Bixalomer)® Capsules in Patients With Hyperphosphatemia Receiving Peritoneal Dialysis

Astellas Pharma Inc0 个研究点目标入组 123 人开始时间: 2013年3月19日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
123
主要终点
Safety assessed by the incidence of adverse events (including adverse drug reactions), vital signs and laboratory tests
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

To evaluate the safety and efficacy of long-term use of Kiklin® Capsules in actual clinical settings.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Chronic renal failure patients with Hyperphosphatemia receiving peritoneal dialysis

排除标准

  • 未提供

研究组 & 干预措施

Kiklin group

Oral

干预措施: bixalomer (Drug)

结局指标

主要结局

Safety assessed by the incidence of adverse events (including adverse drug reactions), vital signs and laboratory tests

时间窗: Baseline and 1, 2, 3, 6, 12 months after administration

次要结局

  • Serum phosphorous levels(Baseline and 1, 2, 3, 6, 12 months after administration)
  • Serum calcium level(Baseline and 1, 2, 3, 6, 12 months after administration)
  • Serum albumin level(Baseline and 1, 2, 3, 6, 12 months after administration)
  • Serum intact PTH (parathyroid hormone) level(Baseline and 1, 2, 3, 6, 12 months after administration)

研究者

申办方类型
Industry
责任方
Sponsor

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