Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of time spent within a Hgb target range
研究概览
简要总结
The purpose of this randomized, controlled pilot study is to evaluate the performance of this novel Anemia Controller (vis-à-vis standard of care) for anemia management in hemodialysis patients. Since the Anemia Controller is designed to bring patients to a pre-defined Hgb target level and keep them there, the target population for this study are patients whose Hgb levels are currently not well-controlled (rather than patients who are already relatively stable within the Hgb target range under a standard anemia management algorithm). Specifically, therefore, the target population for this clinical study are chronic hemodialysis patients who are exhibiting Hgb cycling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 ≥18 years
- •Ability to give written informed consent to the study
- •End-stage renal disease treated with thrice-weekly hemodialysis for at least 180 days preceding enrollment
- •Receiving intradialytic Crit-Line® monitoring, with available Crit-Line® data going back at least 180 days from the date of enrollment
- •Laboratory Hgb data going back at least 180 days from the date of enrollment
- •On average, Hgb values available from at least 2 treatments per week (from either source, Crit-Line® or laboratory) during the past 180 days preceding enrollment
- •Renal anemia treated with intravenous Mircera®, with at least 2 Mircera® dose administrations during the 150 days preceding enrollment
- •On an active Mircera® anemia management algorithm order during the 180 days preceding enrollment
- •Exclusively on Mircera® (no other ESAs) during the 180 days preceding enrollment
- •Pattern of Hgb cycling as defined above during the 180 days preceding enrollment
排除标准
- •Having received the maximum Mircera® dose (225 µg every other week) consistently throughout the 90 days preceding enrollment
- •Hospitalization for more than 10 days during the 30 days preceding enrollment
- •Severe iron deficiency (TSAT <20%, ferritin <100 ng/mL) in the most recent routine blood work prior to enrollment
- •Any known cause of ESA resistance other than iron deficiency and inflammatory states (e.g. hematologic malignancies, hypersplenism, antibody mediated pure red cell aplasia)
- •Simultaneous participation in another clinical study that may impact anemia management or the outcomes of this trial
- •Inability to communicate in English or Spanish
结局指标
主要结局
Percentage of time spent within a Hgb target range
时间窗: 26 weeks
The primary objective of the study is to compare the percentage of time patients will spend within the Hgb target range of 10-11 g/dL when treated with the Anemia Model Predictive Controller (intervention group) vs. when treated with the Standard of Care Algorithm (control group)
次要结局
- ESA accumulated dose (mcg/Kg)(26 weeks)
- Statistical measures of Hgb variability(26 weeks)