Roxadustat Versus Darbepoetin Alfa on Iron Repletion Effects in the Management of Anemia in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Iron profile
研究概览
简要总结
Anemia is a common and debilitating complication of end-stage kidney disease (ESKD) that is associated with reduced quality of life and high morbidity and mortality. ESKD-related anemia is associated with many adverse comorbidities and outcomes; however, normalizing the levels of hemoglobin proved to be insignificant in improving most adverse outcomes. This study aims to evaluate the real-world effectiveness and safety of an ESA and a HIF-PHI in patients with CKD-related anemia.
详细描述
Anemia is a common and debilitating complication of chronic kidney disease (CKD), affecting a significant proportion of patients worldwide. It is approximately twice as prevalent among ESKD patients compared to the general population. The prevalence of anemia increases across the advancing stages of CKD, with estimates anywhere from 7% to >50%. Study Design:
This prospective observational cohort study involved 35 hemodialysis patients at Electricity Hospital, Almaza, Cairo, who were randomly treated with either Roxadustat or Darbepoetin Alfa over 12 weeks. The study aims to assess whether Roxadustat use in the management of ESKD-related anemia results in improved iron profile and reduced iron needs compared with traditional treatment for ESKD-related anemia.
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
- •End-stage kidney disease-related anemia
- •Hemodialysis-related anemia
- •The mean of the two most recent Hemoglobin values before randomization was 10.5mg/dL or less
排除标准
- •ESA treatment 12 weeks before transfusion
- •RBC transfusion 8 weeks before transfusion
- •IV iron transfusion 6 weeks before transfusion
- •Known history of myelodysplastic syndrome
- •Known history of multiple myeloma
- •Known history of hereditary hematologic diseases
- •Active bleeding or any cause of anemia unrelated to CKD
- •NYHA Class III or IV congestive heart failure
- •Liver disease, defined as ALT or AST 3x ULN or greater, or total bilirubin 1.5x ULN or greater
- •Prior organ transplant
研究组 & 干预措施
Darbepoeitin Alpha
Patients are treated with the traditional injectable darbepoetin alfa
Roxadustat
Patients are treated with the oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs)
结局指标
主要结局
Change in Iron profile
时间窗: 12 weeks
The study aims to assess whether Roxadustat usage in the management of CKD-related anemia results in improving iron profile and reducing iron needs compared with traditional treatment for CKD-related anemia.
次要结局
- Kidney Functions(12 weeks)
- Change in hemoglobin levels(12 weeks)
- RBC transfusion rate(12 weeks)
- The need of IV iron(12 weeks)