Effects of the Dose of Erythropoiesis Stimulating Agents on Cardiac-cerebrovascular Outcomes Quality of Life and Costs in Hemodialysis Patients. The Clinical Evaluation of the DOSe of Erythropoietins (C.E. DOSE) Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 656
- 试验地点
- 42
- 主要终点
- TSAT (transferrin saturation), serum albumin, serum ferritin, serum transferrin, serum C reactive protein
研究概览
简要总结
Anaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESAs) are the most used treatment option.
The purpose of this study is
- the evaluation of biochemical markers to determine the efficacy of individual prediction of ESAs therapy
- to determine the benefits and harms of different ESA doses therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD).
详细描述
Phase III pragmatic, randomized-controlled trial comparing different doses of ESAs in patients with renal anaemia.
Study Sample:
Total of 900 participants from Italy
Background and Rationale:
Anaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESA) are the most used treatment option. In observational studies higher haemoglobin (Hb) levels (around 10-13 g/dL) are associated with improved survival and quality of life compared to lower Hb levels (around 9 g/dL). Randomized studies have found that higher Hb targets, achieved and maintained with ESA, cause an increased risk of death, mainly due to adverse cardiac-cerebrovascular outcomes. It is possible that such effect is mediated by ESA dose. This hypothesis has not been formally tested and is the aim of the Clinical Evaluation of the DOSe of Erythropoietins (CEDOSE) trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Age > = 18,
- •End stage kidney disease and anemia
- •Treatment with hemodialysis for renal replacement therapy
- •no contraindications to erythropoietin stimulating agents (ESAs) or already treated with ESAs
排除标准
- •Patients with Hb levels > 10 g/dl without ESAs
结局指标
主要结局
TSAT (transferrin saturation), serum albumin, serum ferritin, serum transferrin, serum C reactive protein
时间窗: after randomization at month 1, 2, 3, 6, 12
次要结局
- Cardiovascular mortality(after randomization at month 1, 2, 3, 6, 12)
- sudden death(after randomization at month 1, 2, 3, 6, 12)
- myocardial infarction(after randomization at month 1, 2, 3, 6, 12)
- hospitalizations due to acute coronary syndrome, transitory ischemic attacks, not planned coronary revascularization, peripheric revascularization.(after randomization at month 1, 2, 3, 6, 12)
- Thrombosis of the cardiovascular access(after randomization at month 1, 2, 3, 6, 12)
- Hypertensive events(after randomization at month 1, 2, 3, 6, 12)
- Quality of life (QoL)(at randomization and at 6 and 12 months)
- composite of all-cause mortality, non fatal myocardial infarction and stroke, hospitalizations due to acute coronary syndrome, transitory ischaemic attacks, not planned coronary revascularization procedures, peripheric revascularization procedures.(after randomization at month 1, 2, 3, 6, 12)
- Stroke(after randomization at month 1, 2, 3, 6, 12)
- Seizures(after randomization at month 1, 2, 3, 6, 12)
研究者
Giovanni FM Strippoli, MD
MD
Consorzio Mario Negri Sud