A Cohort Study of Conversion From Aranesp® to NESP® for the Treatment of Anemia in Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Haemoglobin
研究概览
简要总结
This is a prospective single-arm open-labeled cohort study on dialysis patients of the conversion from Aranesp® to NESP® for the treatment of anemia. The primary outcome of the study is the haemoglobin level after conversion to NESP® after 6 months. Secondary outcomes include the variability in haemoglobin level, average weekly dose of erythropoietin, safety profile of NESP®, patients' subjective assessment of fatigue and injection pain after the conversion.
详细描述
Currently in Hong Kong, Aranesp®, manufactured by Amgen® is the only available Darbepoetin alpha licensed. NESP®, a Darbepoetin alpha agent manufactured by Kirin®, will be replacing Aranesp®.It is important to evaluate the therapeutic equivalence of the two agents, and its efficacy, tolerability and safety profile in the treatment of anemia in dialysis patients. Moreover, a new maximum preparation of NESP 120® microgram will be available to replace the Aranesp® 100 microgram prefilled syringe at the same cost. This larger Darbepoetin alpha preparation may allow extension of dosing intervals. This may subsequently allow cost saving and better convenience to medical staff and patients.
The objectives of this project are:
- To investigate the effectiveness of NESP® in the achieving a stable anemia control in chronic dialysis patients with the same dose conversion from Aranesp®
- To investigate the effectiveness of increasing the dosing interval of NESP® (but maintaining the same total dose) in sustaining a stable anemia control in chronic dialysis patients
- To explore the possibility of cost saving in administering a larger dose NESP® but at an extended interval
Patients will be divided into 3 groups.
Group A. Same dose conversion group
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Adult Chinese patients (age greater than or equal to 18)
- •on long-term dialysis for at least 3 months
- •on Aranesp® treatment for at least 3 months
- •stable hemoglobin level within the range of 9 to12 g/dL, on the same stable dose of Aranesp® within the past 2 months.
- •Minimum weekly kT/V of 1.7 for peritoneal dialysis patients and 1.2 per haemodialysis session for haemodialysis patients
- •Able to give informed consent
排除标准
- •Presence of
- •thalassaemia
- •haematological diseases
- •severe hyperparathyroidism (PTH >90 pmol/L)
- •iron, vitamin B12 or folate deficiency
- •uncontrolled malignancy
- •active blood loss or hemolysis
研究组 & 干预措施
Darbepoetin alfa (NESP®) 120mcg
Patients on Aranesp® 100 mcg preparation (darbepoetin alfa manufactured by Amgen®) will be switched to the NESP® (darbepoetin alfa manufactured by Kirin®)120mcg preparation with slight increase in dosing interval according to the conversion
干预措施: Darbepoetin alfa (Other)
Extended dosing Darbepoetin alfa (NESP®)
Patients on stable dose of Aranesp® (darbepoetin alfa manufactured by Amgen®) will be converted to higher dose preparation of NESP® (darbepoetin alfa manufactured by Kirin®) 40 or 120 mcg preparations) with extended dosing intervals. The total dose of Darbepoetin alpha remains the same.
干预措施: Darbepoetin alfa (Other)
Darbepoetin alfa (NESP®) same dose
Patients on stable low dose Aranesp® (darbepoetin alfa manufactured by Amgen®) (on 20mcg preparations or on 40mcg every 2 weeks or less) will be converted to the same dose of NESP® (darbepoetin alfa manufactured by Kirin®)
干预措施: Darbepoetin alfa (Other)
结局指标
主要结局
Haemoglobin
时间窗: 6 months
次要结局
- average weekly dose of erythropoietin(6 months)
- Variability in haemoglobin level(6 months)
- safety profile of NESP(6 months)
- Subjective assessment of pain(6 months)
- Subjective assessment of fatigue(6 months)
研究者
Dr. Mok Ming Yee
Resident Specialist
The University of Hong Kong