A Randomized Study to Assess the Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis (HD) Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 主要终点
- The number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.0
研究概览
简要总结
The Objective of this study is to assess the Safety and Tolerability of 200 mg and 100 mg of Venofer Administered to Hemodialysis(HD) Patients.
详细描述
This is a randomized open label multi-center study of two parallel patient groups undergoing hemodialysis. Group A will receive 200 mg of iron sucrose, while Group B will receive 100 mg of iron sucrose during the study. The duration of the study for each patient will be approximately 3 weeks including a screening phase, a treatment visit and a follow-up visit.
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
- •Males or females over 18 years of age and able to give informed consent.
- •Undergoing hemodialysis.
- •If receiving epoetin α, then the dose was stable.
- •Percentage serum transferrin saturation (TSAT) <50% and serum ferritin <800 ng/mL.
- •Absence of infection, malignancy, or surgery in the month prior to study start.
- •Intolerance of other iron products did not preclude participation in this study.
排除标准
- •Known sensitivity to any component of Venofer®.
- •Suffering from concomitant severe diseases of the liver, cardiovascular system, severe psychiatric disorders or other conditions which, in the opinion of the investigator, made participation unacceptable.
- •Serious bacterial, viral infection, or other acute infectious illness (e.g., hepatitis) unless completely resolved at least 4 weeks prior to inclusion in the study.
- •Pregnancy or lactation.
- •HIV positive by medical history or laboratory test (optional), or active hepatitis.
- •Anemia caused by diseases (including systemic lupus erythematosus (SLE), rheumatoid arthritis, myeloma, or hereditary hemoglobinopathies) other than chronic renal failure or iron deficiency.
- •Clinical evidence of gastrointestinal bleeding.
- •Would probably require blood transfusion or might undergo a renal transplant during the study.
- •Anticipated surgery of any kind during the study other than vascular access surgery.
- •Received an investigational drug within 30 days prior to screening.
- •Previously participated in another Venofer® study.
研究组 & 干预措施
Venofer® 200 mg
A single 200 mg dose of Venofer® administered by slow intravenous push over 5 minutes.
干预措施: Venofer® 200 mg (Drug)
Venofer® 100 mg
A single 100 mg dose of Venofer® administered by slow intravenous push over 2 minutes without a test dose
干预措施: Venofer® 100 mg (Drug)
结局指标
主要结局
The number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v4.0
时间窗: 3 to 6 days
Any untoward medical events were elicited by nonspecific questions such as "Have you noticed any problems".
次要结局
- The number of participants prematurely discontinued the study due to an adverse event(3 to 6 days)