NCT00548691已完成3 期
A Multi-center, Randomized Controlled Study to Investigate the Safety and Tolerability of IV Ferric Carboxymaltose (FCM) vs Standard Medical Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 513
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-emergent Serious Adverse Events (SAE's)
研究概览
简要总结
The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female 18 to 85 years of age
- •NDD-CKD Patients
- •TSAT </= 25%
- •Hgb </= 11.5
- •Ferritin </= 300
- •HD-CKD Patients
- •TSAT </= 30%
- •Hgb </= 12
- •Ferritin </= 500
排除标准
- •Previous participation in a FCM trial
- •Known Hypersensitivity to FCM
- •History of anemia other that anemia due to chronic renal failure
- •Current history of GI bleeding
- •Received IV Iron within the last 30 Days
- •Anticipated need for surgery
- •Malignancy history
- •AST or ALT greater than normal
- •Received an investigational drug within 30 days of screening
- •Pregnant or sexually active females who are not willing to use an effective form of birth control
研究组 & 干预措施
Ferric Carboxymaltose (FCM)
Experimental
Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
干预措施: Ferric Carboxymaltose (Drug)
Standard Medical Care (SMC)
Active Comparator
SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
干预措施: Standard Medical Care (SMC) (Drug)
结局指标
主要结局
Incidence of Treatment-emergent Serious Adverse Events (SAE's)
时间窗: from Day 0 through 30 days after the last dose of study drug
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum PatientsAnemiaNCT00548860American Regent, Inc.2,018
已完成
3 期
Safety and Tolerability of a Single Dose of FCM vs. Standard of Care in Treating Iron Deficiency AnemiaAnemiaNCT00704353American Regent, Inc.735
已完成
3 期
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency AnemiaAnemiaNCT00704028American Regent, Inc.161
已完成
3 期
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency AnemiaAnemiaNCT00703937American Regent, Inc.708
已完成
3 期
To Assess the Impact of Ferric Carboxymaltose Compared With Iron Sucrose in Chinese Subjects on Correcting Iron Deficiency AnaemiaIron Deficiency AnemiaNCT03591406Vifor (International) Inc.371