临床试验/NCT01518387

NCT01518387已完成3 期

Phase III Open Study of BAY 77 1931 (Lanthanum Carbonate) in Patients With Hyperphosphatemia Undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD)

Bayer0 个研究点目标入组 43 人开始时间: 2006年1月最近更新: 2016年3月14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: 43
主要终点: Change from baseline in serum phosphate levels at the end of the treatment period

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 purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.

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 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Serum phosphate levels: >5.0 mg/dL and <11.0 mg/dL 2 weeks after the initiation of the washout period
•Out-patient
•Undergoing CAPD for at least previous 3 consecutive months

排除标准

•Who may not enable to continue CAPD
•Serum phosphate levels of >=10.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
•Corrected serum calcium level of <7.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after
•Serum intact PTH (Parathyroid) of >=1000 pg/mL at the start of the washout period
•Pregnant woman, or lactating mother
•Significant gastrointestinal disorders including known acute peptic ulcer
•Liver dysfunction
•History of cardiovascular or cerebrovascular diseases

研究组 & 干预措施

Arm 1

Experimental

750-2250mg/day, tid, 8 weeks

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

结局指标

主要结局

Change from baseline in serum phosphate levels at the end of the treatment period

时间窗: Baseline to Week 8

次要结局

Safety variables will be summarized using descriptive statistics based on adverse events collection(8 weeks)
Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement(Week 8)
Serum calcium x phosphate product at the end of the treatment period(Week 8)
Serum calcium level corrected by serum albumin level at the end of the treatment period(Week 8)
Serum intact-PTH (Parathyroid) levels at the end of the treatment period(Week 8)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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