NCT00223977已完成2 期
A Multi-center, Randomized, Open Label Study of the Efficacy and Safety of Two Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peroneal Dialysis Patients Receiving Erythropoietin.
Watson Pharmaceuticals0 个研究点目标入组 146 人开始时间: 2003年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 主要终点
- Hemoglobin
研究概览
简要总结
This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.
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 or female, at least 18 years of age.
- •Received maintenance peritoneal dialysis therapy for at least 4 weeks.
- •Was expected to remain on peritoneal dialysis therapy for duration of study.
- •Had predetermined low hemoglobin and transferrin saturation (TSAT) levels.
- •Signed patient informed consent.
排除标准
- •Had a predetermined serum levels of Ferritin and TSAT
- •Pregnant or lactating.
- •Had a serious concomitant medical disorder incompatible with participation in the study.
- •Had a known hypersensitivity to Ferrlecit or any of its components.
- •Unable to cooperate or comply with the protocol.
研究组 & 干预措施
Sodium ferric gluconate complex 125 mg
Experimental
125 mg sodium ferric gluconate weekly x 8 weeks
干预措施: Sodium Ferric Gluconate Complex (Drug)
Sodium ferric gluconate complex 250 mg
Experimental
250 mg sodium ferric gluconate complex weekly x 4 weeks
干预措施: Sodium Ferric Gluconate Complex (Drug)
Oral iron
Active Comparator
325 mg ferrous sulfate three times daily x 8 weeks
干预措施: Oral Iron (Drug)
结局指标
主要结局
Hemoglobin
时间窗: Baseline to 5 weeks and 9 weeks
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection
次要结局
- Change From Baseline in Transferrin Saturation (TSAT).(Baseline to 5 weeks and 9 weeks)
- Change From Baseline in Hematocrit (Hct)(Baseline to 5 weeks and 9 weeks)
- Change From Baseline in Serum Ferritin.(Baseline to 5 weeks and 9 weeks)
- Responders by Treatment Group(Baseline to 5 weeks and 9 weeks)
研究者
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