Effects Intravenous Iron and Oral Iron Therapy on Erythropoietin Dose in Maintenance Hemodialysis Patients: An Open-label, Randomized, Controlled Study
试验速览
- 阶段
- 3 期
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Changes of epoetin dose
研究概览
简要总结
This study is aim to compare the efficacy of intravenous versus oral iron therapy regarding the hemoglobin levels, iron status and erythropoietin dosage in maintenance hemodialysis patients
详细描述
Run-in phase: All eligible patients will enter run-in phase for 2 weeks. In this phase, all oral therapy that patients received before enrolment into the study will be discontinued.
Masking: Opened label
Allocation: Block of four randomization into 2 treatment arms: intravenous iron and oral iron
Safety criteria: Study participants who meet the following criteria will be discontinued from the study. All patients data will be analyzed according to intention-to-treat principles.
- Hemoglobin levels < 6.0 g/dl
- Packed red cells transfusion is required
- Serum ferritin >1,000 md/dl
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
- Single (Outcomes Assessor)
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 years
- •Hemodialysis for at least 3 months
- •Hemoglobin levels between 8 and 11.5 g/dl inclusive
- •Transferrin saturation (TSAT) <50% and ferritin <800 mg/dl
- •Stable dose of epoetin of any types and iron therapy for at least 1 month
排除标准
- •History of iron allergy
- •Pregnant or lactating women
- •Patients with known hematologic disorders other than anemia of renal disease and iron deficiency anemia
- •Patients with hemoglobinopathy e.g., thalassemia
- •Patients with iron overload or hemochromatosis
- •Patients with gastrointestinal hemorrhage during 6 months before enrolment in to the study
- •Patients with current severe infection
- •Patients with any malignancies
- •Patients with severe psychiatric illness
- •Patients with any other medical condition which, in the Investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes
- •Patients who currently receive medications that can altered gastrointestinal absorption of oral iron e.g., aluminum carbonate, aluminum hydroxide, chloramphenicol, dimercaprol
研究组 & 干预措施
Intravenous iron
Iron sucrose 200 mg every 2 weeks Folic acid 5 mg/day B6 10 mg/day
干预措施: Intravenous iron (Drug)
Oral iron
Ferrous fumarate 600 mg/day Folic acid 6.5 mg/day B6 15 mg/day
干预措施: Oral iron (Drug)
结局指标
主要结局
Changes of epoetin dose
时间窗: 24 weeks after randomization
Hemoglobin levels will be monitored and epoetin dose will be adjusted according to hemoglobin levels at 4, 12, 24 weeks after randomization. Protocols for epoetin dose adjustments are shown as follow. Hemoglobin levels (g/dl) Epoetin dose adjustment \<9.0 Increased by 50% 9.0 to \<10.0 Increased by 25% 10.0 to \<11.5 No change 11.5 to \<12.5 Decreased by 25% * 12.5 Decreased by 50%
次要结局
- Unscheduled hospitalization(24-week period after randomization)
- C-reactive protein (CRP)(4, 12, 24 weeks after randomization)
- The kidney disease quality of life (KDQOL) instrument(4, 12, 24 weeks after randomization)
- Hospitalization due to infections(24-week period after randomization)
- Cost-effectiveness of iron therapy(4, 12, 24 weeks after randomization)
- Erythropoietin resistance index(4, 12, 24 weeks after randomization)
- Major cardiovascular events (MACE)(24-week period after randomization)
- Quality of life will be assessed by EQ-5D-5L (EuroQol - 5 Dimensions - 5 Levels)(4, 12, 24 weeks after randomization)
- Hemoglobin levels(4, 12, 24 weeks after randomization)
研究者
Kajohnsak Noppakun
Assistant Professor of Medicine
Chiang Mai University