An International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Haemodialysis Patients With Anaemia Treated With Biosimilar Epoetin Alfa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 2,086
- 试验地点
- 1
- 主要终点
- Haemoglobin outcomes, including haemoglobin levels in g/dL, change in haemoglobin levels over time (in g/dL and %), number and proportion of patients with haematopoietic response, number and proportion of patients reaching target haemoglobin levels.
研究概览
简要总结
MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin alfa in Stage 5 CKD patients requiring haemodialysis.
详细描述
See the following publication:
Gesualdo, L., London, G., Turner, M., Lee, C., MacDonald, K., Covic, A., Zaoui, P., Combe, C., Dellana, F., Muenzberg, M., & Abraham, I. (in press). A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anemia in hemodialysis patients: background and methodology of the MONITOR-CKD5 study. Internal and Emergency Medicine. (DOI 10.1007/511739-011-0622-7)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults (age > 18 years).
- •On chronic haemodialysis due to end-stage renal disease (CKD5) of original or grafted kidneys for any duration.
- •Diagnosed with renal anaemia; i.e., anaemia due to impaired production of endogenous erythropoietin secondary to kidney failure.
- •Treated with commercially available intravenous EPOETIN ALFA HEXAL® per physician's best clinical judgment and under consideration of available guidance and evidence.
- •Female patients must be either post-menopausal for one year or surgically sterile or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Oral contraceptive use is allowed.
- •Informed written consent to participate in the study by patients or their legal guardian.
排除标准
- •Known sensitivity to EPOETIN ALFA HEXAL® or any other ESA.
- •Solid or hematological neoplasia being treated with chemotherapy.
- •Treatment with any myelosuppressant medications.
- •Blood transfusion dependency.
- •History of pure red cell aplasia.
- •Bleeding episode in 30 days prior to enrollment.
- •Orthopaedic surgery in 30 days prior to enrollment.
- •Patients with several medical condition(s) that in view of the investigator prohibits participation in the study.
- •Patients with willfully negligent nonadherence to their haemodialysis, medication, nutrition, and/or other recommended treatment regimens.
- •Use of any investigational agent in the 30 days prior to enrollment.
- •Women of childbearing potential not using the contraception method(s) described above.
- •Women who are breastfeeding.
研究组 & 干预措施
CKD5, renal anaemia, haemodialysis
CKD5, renal anaemia, haemodialysis receiving recombinant human erythropoietin alfa (biosimilar)
干预措施: Recombinant human erythropoietin alfa (biosimilar) (Drug)
结局指标
主要结局
Haemoglobin outcomes, including haemoglobin levels in g/dL, change in haemoglobin levels over time (in g/dL and %), number and proportion of patients with haematopoietic response, number and proportion of patients reaching target haemoglobin levels.
时间窗: every month for 24 months
次要结局
- Number and proportion of participants with thrombovascular events, hospitalization,and mortality as measures of safety.(Every month for 24 months + as occurring between visits)