A Multi-Centre, Open Label, Randomized, Parallel Group Pilot Study to Assess the Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease

Shire0 个研究点目标入组 48 人开始时间: 2005年1月7日最近更新: 2021年7月6日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Shire
入组人数: 48
主要终点: Mean pre-dialysis serum phosphate level

研究概览研究设计入排标准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 phosphate reduction and control in patients with End Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients receiving haemodialysis for ESRD
•Patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months

排除标准

•Pregnant or lactating women
•Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
•Patients who are HIV+
•Patients with any significant bowel obstruction, active inflammatory bowel disease, GI motility disorders, or a history of major GI surgery within the last 6 months

结局指标

主要结局

Mean pre-dialysis serum phosphate level

时间窗: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)

次要结局

Treatment emergent adverse events(Throughout the study period of approximately 7.5 months.)
Mean pre-dialysis serum calcium product(The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8))
Mean pre-dialysis calcium-phosphate product(The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8))
Average daily pill burden(Daily throughout for the 8 week Evaluation for Dose Adjustment Period up to the End of Study/ Withdrawal Visit.)

研究者

发起方

Shire

申办方类型

Industry

责任方

Sponsor

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