A Long Term, Open Label Extension Study of Protocols LAM-IV-301, LAM-IV 303, LAM-IV 307 AND LAM-IV 308.

Shire0 个研究点目标入组 93 人开始时间: 2002年10月14日最近更新: 2021年6月23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: 93
主要终点: Treatment emergent adverse events

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 the safety of lanthanum carbonate in patients undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to continue treatment.

研究设计

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

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Patients who participated in LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 and received lanthanum carbonate
•Patients must continue to require treatment with a phosphate binder for hyperphosphatemia
•male or non-pregnant female who agrees to use an effective contraceptive method while on study treatment and for 30 days thereafter

排除标准

•Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization
•Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication
•Pregnant or lactating women

结局指标

主要结局

Treatment emergent adverse events

时间窗: Up to 24 months

次要结局

Plasma lanthanum levels(Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.)
Changes in pre-dialysis serum phosphate levels(Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.)
Control of pre-dialysis serum phosphate levels(Baseline, Months 3, 6, 9, 12, 15, 18, 21, 24.)

研究者

发起方

Shire

申办方类型

Industry

责任方

Sponsor

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