The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Intraindividual Hemoglobin (Hgb) variability
研究概览
简要总结
Hypothesis: Routine clinical tests with feedback control based Epogen(Epo)/Venofer(Iron) protocol will improve Hemoglobin (Hgb) stability and increase the time that patients remain in target
Objectives:
- Decreased variability of Hgb
- Increase the % of patients in target range c Increase in time that Hgb remains target range
详细描述
Study Design One dialysis unit shift comprising up to 200 patients. Study participation will last for 12 months broken into 3 phases as described below.
Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care.
Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP.
The individual AMP will be utilized weekly during the 9 months of Phase 2.
The 3 objectives will be evaluated and updated weekly, Baseline to Year 1.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •Receiving hemodialysis in an out-patient dialysis unit
排除标准
- •Not receiving EPOGEN as part of their standard medical care
- •Patient refusal
结局指标
主要结局
Intraindividual Hemoglobin (Hgb) variability
时间窗: Evaluated and updated weekly for 52 weeks
Change in average intraindividual Hgb variability between control period and treatment periods.
次要结局
- Average hemoglobin levels(Evaluated and updated weekly for 52 weeks)
研究者
Michael Germain
Medical Director, Renal Transplantation, Department of Medicine
Baystate Medical Center