Short Versus Long-Acting Erythropoiesis Stimulating Agents for Anemia Management in Egyptian Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Percentage of patients reaching the target Hemoglobin in each group.
研究概览
简要总结
This observational study aims to compare long-acting darbepoetin alpha versus short-acting epoetin alpha erythropoietin-stimulating agents in Egyptian hemodialysis patients. The main questions aim to answer are:
- What are the effectiveness and safety of long- acting versus short-acting erythropoietin-stimulating agents in Egyptian hemodialysis patients?
- What is the cost-effectiveness of long- acting versus short-acting erythropoietin-stimulating agents in Egyptian hemodialysis patients?
Participants will be divided into 2 groups; epoetin alfa (short-acting ESA), Eprex group, and darbepoetin alfa (long-acting ESA), Aranesp group for six month study period.
详细描述
Anemia, the most prevalent and dangerous complication of chronic kidney disease, is caused when the kidney is unable to produce enough erythropoietin to promote the creation of red blood cells (CKD). Anemia from CKD is linked to higher mortality, cardiovascular disease, exhaustion, dyspnea, and a lower quality of life for patients.
It has been demonstrated that using erythropoietin-stimulating drugs (ESAs) in treating renal anemia increases survival, lowers cardiovascular morbidity, and improves the quality of life.
Epoetin alfa (EPO), an ESA with a shorter half-life, and darbepoetin alfa (DPO), are the two ESAs used in hemodialysis centers the most frequently in Egypt (longer half life ) Epoetin alfa is dosed one to three times per week, whereas darbepoetin alfa is dosed once per week or every two weeks.
Compared to epoetins, darbepoetin alfa's extended dose interval may benefit patients and their medical professionals.
Despite the fact that ESAs save CKD patients from needing blood transfusions, clinical trials, meta-analyses, and mortality hazards with ESAs targeting high hemoglobin levels have been shown. A higher ESA dose may be linked to cardiovascular problems and all-cause mortality independent of hemoglobin level.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been stable and undergoing hemodialysis three times per week for at least three months
- •Age must be 18 or older
- •Patients who had been receiving a single form of ESA treatment for at least three months before the study's launch.
排除标准
- •altered the type of ESA therapy; 2) underwent significant surgery; or (3) received RBC transfusions
- •failed to adhere to dialysis therapy, as shown by missing more than two appointments each month.
- •have COVID-19 infection.
- •had cancer.
- •underwent a kidney transplant
- •were pregnant or nursing mothers
- •were not followed up for the full six-month research period.
结局指标
主要结局
Percentage of patients reaching the target Hemoglobin in each group.
时间窗: baseline to six months
Assess the percentage of patients reaching the target Hemoglobin (10-11.5 g/dl) in each group during the study period.
次要结局
- Analyze the cost-effectiveness of long-acting (DPO) versus short-acting (EPO) erythropoietin-stimulating agents in hemodialysis patients.(baseline to six months)
研究者
Salma Magdy Abdelfattah
Teaching Assistant
Helwan University