临床试验/NCT01187628

NCT01187628已完成3 期

An Open-label, Long-term Extension Study of Lanthanum Carbonate 750 to 2,250 mg in Hyperphosphatemia in Patients With Chronic Kidney Disease Not on Dialysis (52 Weeks Extension From Study 14817)

Bayer0 个研究点目标入组 123 人开始时间: 2010年9月最近更新: 2015年4月3日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Bayer
入组人数: 123
主要终点: Incidence of treatment emergent adverse events

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

The objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 20 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients who have completed the 8-week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study).

排除标准

•Patients with any other conditions that the investigator defines as not appropriate to be enrolled in the study

研究组 & 干预措施

Arm 1

Experimental

干预措施: Fosrenol (Lanthanum Carbonate, BAY77-1931) (Drug)

结局指标

主要结局

Incidence of treatment emergent adverse events

时间窗: baseline to Week 60

次要结局

未报告次要终点

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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