NCT01306409已完成4 期
Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Reticulocyte count on day 7
研究概览
简要总结
The purpose of this study is to gain information on reticulocyte neocytolysis in patients treated with ESA with regard to different types of ESA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •signed informed consent
- •age > 18 years, dialysis dependent chronic renal failure
- •hemodialysis three times a week
- •Kt/V > 1,2 od URR > 65%
- •hemoglobin between 11 and 13 g/dl within the last 2 months
- •hemoglobin change +/- 1g/dl within the last 4 weeks
- •ESA for at least 8 weeks
- •Ferritin > 300 ng/ml and Tsat > 25%
排除标准
- •Significant bleeding in the last 8 weeks
- •blood transfusion within the last 8 weeks
- •hemoglobin disorder
- •hemolysis
- •Malignant disease
- •Significant inflammation
- •Acute infection
- •CRP > 30 mg/l
- •Temporary vascular dialysis access
- •Vitamin B12 deficiency
- •Folic acid deficiency
- •Not controlled hyperparathyroidism
- •Not controlled hypertension
- •Epilepsia within thze last 6 months
- •Thrombocyte count > 500 x 10^9 /l
研究组 & 干预措施
A
Experimental
Sequential application of different ESA
干预措施: cera, darbepoetin, epoetin-beta (Drug)
A
Experimental
Sequential application of different ESA
干预措施: ESA (Drug)
结局指标
主要结局
Reticulocyte count on day 7
时间窗: day 7
次要结局
未报告次要终点
研究者
研究点 (1)
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