The Response of Continuous Erythropoietic Receptor Activator (CERA) With Different Dose Interval and the Survey for Influence Factors
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Erythropoietic response
研究概览
简要总结
The response of Continuous Erythropoietic Receptor Activator (CERA) with different dose interval and the survey for influence factors:
We aim to evaluate a better clinical response which can be achieved by different dosing interval of a fixed dose of CERA. We expect this study can determine the dosing schedule with better clinical response to CERA and identify the associated factors predicting the cost-effectiveness of CERA in maintenance hemodialysis (HD) patients in Taiwan.
详细描述
We included HD patients with stable hematocrit (between 30~36%) under intravenous administration of CERA 100 μg once monthly for two months. Then they were shifted to receive CERA 50μg twice monthly for anther two months and finally they were shifted back to receive CERA 100 μg once monthly again for additional two months. Then we measured and compared the erythropoietic response (hematocrit, hemoglobin), profiles of iron status as well as nutritional status and inflammatory markers among the study subjects every two months for a total of 6 months. Those who had bleeding or received surgery or blood transfusion were excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HD patients with stable hematocrit (between 30~36%) under intravenous administration of CERA 100 μg once monthly for two months.
排除标准
- •HD patients were excluded due to active bleeding (major trauma, gastric ulcer bleeding, or surgery), blood transfusion or administration of additional erythropoietic stimulating agent (ESA) other than CERA within the follow-up period during the study perod of 6 months. People who discontinued CERA as their ESA were also excluded.
研究组 & 干预措施
CERA
We included HD patients with stable hematocrit (between 30~36%) under intravenous administration of CERA 100 μg once monthly for two months. Then they were shifted to receive CERA 50μg twice monthly for anther two months and finally they were shifted back to receive CERA 100 μg once monthly again for additional two months. Then we compared the hematocrit, nutrition status and inflammation markers every two months for 6 months totally. Those who had bleeding or received surgery or blood transfusion were excluded.
干预措施: CERA (Drug)
结局指标
主要结局
Erythropoietic response
时间窗: every 2 months for six months
We measured and compared the hematocrit, hemoglobin, and iron status profiles (ferritin, iron, total iron binding capacity) among those enrolled patients every 2 months for 6 months totally.
次要结局
- Nutritional status and inflammatory markers(every 2 months for a total of 6 months)
研究者
vghtpe user
Chih-Ching Lin,M.D PhD.
Taipei Veterans General Hospital, Taiwan