Heme Iron Polypeptide for the Treatment of Iron Deficiency Anemia in Pre-Dialysis Patients: A Pilot Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Hemoglobin Concentration at 6 Months
研究概览
简要总结
The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with chronic kidney disease.
详细描述
Iron deficiency anemia is common in patients with pre-dialysis chronic kidney disease, and is associated with significant morbidity. Conventional treatment with oral iron salts or IV iron formulations are costly and are associated with side effects. Heme iron polypeptide is a newly available formulation of oral iron which can be administered orally, is well absorbed by uremic patients, and has potentially fewer side effects.
Comparison: Iron deficient anemic patients will be randomized to either oral heme iron polypeptide or IV iron sucrose for six months.
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 (Investigator)
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
- •eGFR < 30 mL/min
- •Hb 90-110 g/L
- •Age > 18
- •Not on renal replacement therapy
- •Transferrin saturation < 20% OR Ferritin <100 mcg/L
- •B12 & folate within reference range
排除标准
- •Iron overload (Tsat > 50% or ferritin > 800 μg/L);
- •malignancy; recurrent gastro-intestinal bleeding, major surgery or infection within the last 3 months;
- •parenteral iron therapy, blood transfusion within the last 3 months;
- •contraindication to any study medication and;
- •inability or refusal to give consent.
研究组 & 干预措施
Heme Iron
Heme Iron Polypeptide 11mg PO tid for 6 months
干预措施: Heme Iron Polypeptide (Proferrin) (Drug)
Venofer
Venofer q month IV x 6 months
干预措施: Iron sucrose (Venofer) (Drug)
结局指标
主要结局
Hemoglobin Concentration at 6 Months
时间窗: 6 months
次要结局
- Ferritin(6 months)
- Transferrin Saturation(6 Months)