An Observational Study of South African Dialysis Patients Treated With Aranesp
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Haemoglobin Concentration
研究概览
简要总结
An observational study to describe the treatment of anaemia in patients with chronic kidney disease, who are receiving dialysis treatment at selected study centres in South Africa.
详细描述
This multicentre, prospective, observational study will describe the treatment and clinical outcomes of of dialysis patients in South Africa. No formal hypothesis will be tested in this descriptive study. Eligible subjects will be receiving either peritoneal or haemodialysis, will have received Aranesp therapy between 3 and 6 months prior to enrolment into the study, do not need to be receiving Aranesp at the time of enrolment and will be followed for up to 12 months after commencement of Aranesp. Data to be collected includes ESA therapies, iron usage, relevant concomitant therapies, haemoglobin concentrations, other relevant clinical laboratory parameters and red cell transfusions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing chronic haemodialysis or peritoneal dialysis
- •Commenced Aranesp therapy 3-6 months prior to enrolment
- •Erythropoiesis stimulating agent (ESA) naive or treated with another ESA prior to commencing Aranesp
- •Informed consent obtained
排除标准
- •Received Aranesp in an interventional study within 6 months prior to start of observation period
- •Receive investigational product during the observation period
研究组 & 干预措施
Study population
Single cohort of dialysis patients
干预措施: Aranesp (Drug)
结局指标
主要结局
Haemoglobin Concentration
时间窗: Each 4-week period for the duration of the study period (15 months)
Due to the premature termination of the study no outcome measure data were analyzed.
次要结局
- Hemoglobin Excursions(Over the 15-month observation period)
- Hemoglobin Within the Range 10-12 g/dL Over Time(On a continuous basis over the 15-month observation period)
- ESA/Aranesp Dose Ratio(Day of commencement of Aranesp)
- Iron Therapy Use(Over the 15-month observation period)
- Use of Concomitant Therapies: Immunosuppressants, Cardiovascular Medications, Secondary Hypoparathyroidism Medications, Anti-retroviral Therapy(At each 12-week interval over the observation period)
- Number of Hospitalisations(Over the 15-month observation period)
- Erythropoiesis Stimulating Agent (ESA) Usage(Over the 15-month observation period)
- Number of Red Blood Cell Transfusions(Over the 15-month observation period)
- C-Reactive Protein, Albumin, Transferrin Saturation and Serum Ferritin Concentration(Over the 15-month observation period)