NCT00563446已完成不适用
Conversion From Once Weekly Recombinant Human Erythropoietin to Once Monthly Darbepoetin Alfa for the Treatment of Renal Anemia in Continuous Ambulatory Peritoneal Dialysis Patients
Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2005年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Hemoglobin level
研究概览
简要总结
Anaemia is a common consequence of chronic renal failure. Darbepoetin alfa is a unique erythropoietic protein that stimulates erythropoiesis by the same mechanism as endogenous erythropietin and conventional recombinant human erythropoietin (rHuEPO). Darbepoetin alfa has been shown to have a serum half-life 3-fold longer than that of rHuEPO, which allows dosing at extended intervals and less frequent injection.
The objective is to evaluate the efficacy and safety of darbepoetin alfa therapy given at an extended once monthly dosing interval in the treatment of renal anaemia in continuous ambulatory peritoneal dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on continuous ambulatory peritoneal dialysis
- •Patients receiving subcutaneous recombinant human erythropoietin (rHuEPO)
- •Patients with haemoglobin level ?10 g/dL and remain stable for the past 3 months while receiving rHuEPO
排除标准
- •Uncontrolled hypertension
- •Severe congestive heart failure (NYHA class III or IV)
- •Grand mal epilepsy
- •Any kind of blood loss causing Fe depletion
- •Presence of infection, either acute or chronic, or inflammatory conditions within 3 months preceding the study
- •Malignancy
- •Aluminum toxicity
- •Severe hyperparathyroidism with marrow fibrosis or osteitis fibrosa _ PTH > 20 times of normal
- •Vitamin B12 or folate deficiency _ MCV > 100fL
- •Haemolysis
- •Marrow dysfunction e.g. aplastic anaemia, myelodysplastic syndrome, multiple myeloma, etc
- •Thalassaemia major, intermediate or minor, or red cell enzyme defects
- •Blood transfusion within 3 months preceding the study
- •Pregnancy or lactating mothers
结局指标
主要结局
Hemoglobin level
时间窗: Over 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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