Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Time for hematocrit to rise
研究概览
简要总结
The purpose of this research study was to determine if the activity of erythropoietin (r-HuEPO) is time dependent when given to chronic renal failure patients at three different times of day.
详细描述
This phase-II crossover study was designed to test if the activity of erythropoietin is time dependent. Patients with chronic renal failure on hemodialysis requiring r-HuEPO to maintain adequate levels of hematocrit are eligible for the study. Patients were administered r-HuEPO subcutaneously three times per week, 50 U/kg, rounded to the nearest 2000 units. r-HuEPO will be administered until the hematocrit rises from the baseline level of 20-24% to the target level of 30-34%. This will be repeated three times, each at different times of day, either 0800, 1500 or 2200 hrs and the order of these will be randomly determined. Each patient will complete all three of the phases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Chronic renal failure patients requiring hemodialysis and requiring r-HuEPO to maintain adequate hematocrit levels
- •Serum ferritin level > 200 micrograms/L and transferrin saturation > 15%
- •Serum erythropoietin level less than 500 mu/ml (when off r-HuEPO)
- •Prior therapy with r-HuEPO
- •An adequate program of dialysis established
- •Informed consent signed
排除标准
- •Adocumented cause of anemia other than chronic renal disease
- •Symptoms of unstable coronary artery disease
- •Poorly controled hypertension
- •Known seizure disorder
- •Other active inflammatory or infective disorders
- •Other disorders that may diminish the response of the bone marrow to r-HuEPO
研究组 & 干预措施
0800
r-HuEPO administered at 0800 hrs
干预措施: r-HuEPO (Drug)
1500
r-HuEPO administered at 1500 hrs
干预措施: r-HuEPO (Drug)
2200
r-HuEPO administered at 2200 hrs
干预措施: r-HuEPO (Drug)
结局指标
主要结局
Time for hematocrit to rise
次要结局
未报告次要终点