Efficacy of Reticulocyte Hemoglobin Equivalent-guided Versus Transferrin Saturation-guided Iron Supplement Protocol in Hemodialysis Patients: A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Erythropoietin resistance index (ERI) [non-inferiority]
研究概览
简要总结
The goal of this clinical trial is to find out which method is better for guiding iron treatment in adult patients with end-stage kidney disease (ESKD) on hemodialysis who have anemia.
The main questions it aims to answer are:
Can using reticulocyte hemoglobin equivalent (RET-He) to guide intravenous (IV) iron treatment be as effective as using transferrin saturation (TSAT)?
Does the method used to guide iron treatment affect outcomes such as death, heart problems, hospitalizations, infections, or the need for blood transfusions?
Researchers will compare RET-He-guided iron treatment with TSAT-guided iron treatment to see if RET-He works just as well and has similar or better outcomes.
Participants will:
Receive IV iron based on either RET-He or TSAT levels
Have blood tests done at the start, 3 months, and 6 months
Have their doses of iron and erythropoietin (a medication to treat anemia) adjusted based on the assigned protocol
Be monitored for clinical outcomes such as hospitalization, heart events, and infections
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (age 18-80 years)
- •ESKD on chronic hemodialysis ≥ 6 months
- •EPO therapy ≥ 6 months
- •Hb < 13.0 g/dL in male, < 12.0 g/dL in female
排除标准
- •Serum ferritin > 800 ng/mL or TSAT > 40%
- •Active infection or malignancy
- •Hematologic disease including thalassemia major, hemolysis, myelofibrosis or myelodysplastic disease
- •History of marrow suppressive or immunosuppressive medications in past 6 months
- •History of active heart failure and recent myocardial infarction /stroke in past 6 months
- •History of GI or external bleeding or receiving blood transfusion in past 6 months
结局指标
主要结局
Erythropoietin resistance index (ERI) [non-inferiority]
时间窗: 6 months
The erythropoietin resistance index (ERI, Unit/week/g/dL) is calculated by dividing the weekly body-weight-adjusted epoetin dose (international units per kilogram per week) by the hemoglobin concentration (grams per deciliter) The pre-specified non-inferiority margin is 20% (approx. 160 Unit/week/g/dL) Pre-specified subgroup analysis will be conducted: Patients with and without thalassemia trait will be separately analyzed
次要结局
- All cause death(6 months)
- Cardiovascular events(6 months)
- Blood Transfusions(6 months)
- Hospitalizations(6 months)
- Incidence of infection(6 months)
研究者
Jeerath Phannajit
Chief, Division of Clinical Epidemiology, Department of Medicine
King Chulalongkorn Memorial Hospital