A Multi-center, Open-label, Randomized, Parallel Group Study of the Efficacy and Safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 112
- 主要终点
- The primary objective of this study is to evaluate the efficacy of two dose levels of Ferrlecit when compared with oral iron when administered as maintenance therapy in iron-replete hemodialysis patients who are receiving Erythropoietin.
研究概览
简要总结
This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving Erythropoietin.
详细描述
A Multi-Center, Open-Label, Parallel Group Study of the efficacy and safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin. Patients with normal iron indices receive one of two doses of Ferrlecit administered weekly throughout the treatment period. Efficacy was assesses at designated timepoints throughout the study and after the last Ferrlecit dose.
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
- •Male of female, 18 years old or older.
- •Have been receiving chronic hemodialysis therapy
- •On stable EPO dosing regimen.
- •Have signed patient informed consent.
- •Predetermined serum ferritin and TSAT levels.
- •Clinical instability - inability to achieve adequate dialysis, abnormal serum albumin and serum glucose.
- •Pregnant or lactating.
- •A known sensitivity to Ferrlecit
排除标准
- •Scheduled for renal transplant.
- •A serious concomitant medical disorders incompatible with participation in the study.
- •Unable to cooperate or comply with the protocol.
- •Use of any investigation agent within 30 days prior to study or during the course of the study.
- •Judged by the investigator as unsuitable for enrollment for any reason.
研究组 & 干预措施
1
Oral Iron
干预措施: Oral Iron (Drug)
2
sodium ferric gluconate
干预措施: sodium ferric gluconate (Drug)
3
sodium ferric gluconate
干预措施: sodium ferric gluconate (Drug)
结局指标
主要结局
The primary objective of this study is to evaluate the efficacy of two dose levels of Ferrlecit when compared with oral iron when administered as maintenance therapy in iron-replete hemodialysis patients who are receiving Erythropoietin.
时间窗: 22 weeks
次要结局
- The secondary objectives of this study include comparisons between Ferrlecit treatments to oral iron regarding changes from baseline in hematological parameters, iron indices, EPO requirements and safety.(22 weeks)