NCT00224055已完成4 期
A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease
Watson Pharmaceuticals0 个研究点目标入组 89 人开始时间: 2003年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 主要终点
- Change in Hemoglobin (Hgb)
研究概览
简要总结
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).
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
- •Moderate to severe anemia
- •Iron deficiency
- •Moderate to severe chronic kidney disease
排除标准
- •Receiving dialysis
- •Known sensitivity to Ferrlecit® or any of its components
- •Receiving therapy with erythropoietic agent
- •Clinically unstable
研究组 & 干预措施
IV iron
Experimental
Sodium ferric gluconate
干预措施: Sodium Ferric Gluconate Complex in Sucrose Injection (Drug)
oral iron
Active Comparator
ferrous sulfate
干预措施: Ferrous sulfate tablets (Drug)
结局指标
主要结局
Change in Hemoglobin (Hgb)
时间窗: Baseline to 10 weeks
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
次要结局
- Change in Serum Ferritin(Baseline to 10 weeks)
研究者
相似试验
已完成
4 期
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic AgentsAnemia, Iron-DeficiencyKidney Failure, ChronicNCT00224042Watson Pharmaceuticals52
招募中
3 期
Sucrosomial Iron vs. Oral Iron Sulfate for the Treatment of Iron Deficiency Anemia in Patients With Ulcerative ColitisAnemia, Iron DeficiencyUlcerative ColitisNCT05225545American University of Beirut Medical Center30
已完成
1 期
Bioequivalence Study With Pharmacokinetic Endpoints, Comparing a Single Dose of Iron Sucrose Azad Injection of Azad Pharma Corporation (AG), With a Single Dose of Venofer® Injection of Vifor Corporation (AG) in Healthy Adult VolunteersHealthy VolunteersNCT02391181Azad Pharma AG30
已完成
4 期
IV Iron in Acute Decompensated Heart FailureHeart FailureNCT04063033Rambam Health Care Campus34
已完成
2 期
Iron Supplementation of Lead-exposed InfantsLead ToxicityNCT00374790Cornell University50