Interest of the Peak of Reticulocytes in Chronic Hemodialysis Patients Treated by Mircera
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 94
- 试验地点
- 13
- 主要终点
- Reticulocyte peak
研究概览
简要总结
Patients under hemodialysis treatment are mostly treated by erythropoietin (EPO) through erythropoiesis stimulating agents (ESA). The objective of ESA treatments is to maintain the hemoglobin level in a therapeutic target around 11g/dl. The EPO dose that is necessary to reach this target depends on numerous and imbricated factors such as age, associated pathologies, iron status, inflammation. As of today, there is no marker to predict the EPO response and Hemoglobin (Hb) level is currently the only and late tool to assess the efficacy.
详细描述
Reticulocytes are immature red blood cells that are temporary present in the blood circulation. They are easily monitored on every automatic dosing machines. Nevertheless, among the dialysis population, they are seldom used and attempt to define a normal reticulocyte level, attesting a correct medullar response to the administrated EPO dose failed due to the timing of blood collection (corresponding to the Nadir day of reticulocytosis).
In a preliminary study, it has shown that reticulocyte count kinetics depends on ESA's type, dose and administration frequency. Reticulocyte kinetics were compared in three groups of stable dialysis patients, depending on their ESA treatment. Reticulocyte curves under a monthly Mircera® treatment were different from the other ESAs, showing a high reticulocyte peak (av. 80 000 reticulocyte/ml) occurring on Day (D)8-D10 after Mircera® administration. On the contrary, at nadir's point (D20-D30 after injection), reticulocyte levels are low for all the patients, preventing from any interpretation of the reticulocyte level at monthly routine assessment. It looks as though it is the peak level of reticulocytes that should be used as a marker of ESA response.
Therefore, monitoring of reticulocytes would support the therapeutic decision on the need to adapt the EPO dose.
The study is design to determinated the interest of the reticulocyte peak in the daily practice
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age> or equal to 18 years
- •Patients on hemodialysis or hemodiafiltration for at least 3 months
- •Patient treated monthly by Mircera® for at least one month
- •Affiliate or enjoying a social security scheme
- •Patients who received oral and written information about the study, with no objection to the use of personal data and having signed an informed consent form and written
排除标准
- •Patient who refused to give his written consent to the study
- •Patients treated with another Erythropoiesis stimulating agent
- •Pregnant or breastfeeding women
- •Major under guardianship
结局指标
主要结局
Reticulocyte peak
时间窗: Day 9
variation of the reticulocyte peak compared with hemoglobin level
次要结局
- Mean reticulocyte peak(6 months)