临床试验/NCT00223964

NCT00223964已完成4 期

Randomized Double-Blind Parallel Group MultiCenter Study of the Efficacy of Two Doses of Ferrlecit® in Treatment of Iron Deficiency in Pediatric Hemodialysis Patients Receiving Epoetin.

Watson Pharmaceuticals0 个研究点目标入组 59 人开始时间: 2003年6月最近更新: 2012年8月14日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 59
主要终点: Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy.

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

This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.

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: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 2 Years 至 16 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Male or female pediatric end-stage renal disease (ESRD) patients.
•Predetermined TSAT and serum ferritin levels
•Receiving chronic hemodialysis therapy with an identified need for repletion iron therapy.
•Receiving a stable epoetin (EPO) dosing regimen.

排除标准

•Receipt of any form of iron supplements during the 4 weeks prior to the first Ferrlecit® dosing.
•Blood transfusion.
•Hypersensitivity to Ferrlecit®.
•Significant inflammatory conditions.

研究组 & 干预措施

dose level 1

Experimental

1.5 mg/kg

干预措施: Ferrlecit (sodium ferric gluconate complex in sucrose injection) (Drug)

dose level 2

Experimental

3 mg/kg

干预措施: Ferrlecit (sodium ferric gluconate complex in sucrose injection) (Drug)

结局指标

主要结局

Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy.

时间窗: 2 weeks

次要结局

Evaluate single-dose pharmacokinetics of Ferrlecit® in iron deficient pediatric hemodialysis patients and to access the safety profile of Ferrlecit® in pediatric hemodialysis patients.(48 hours)

研究者

发起方

Watson Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

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