跳至主要内容
临床试验/NCT01864161
NCT01864161已完成4 期

Endovenous Versus Liposomal Iron in CKD

Federico II University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年10月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
modification in hemoglobin levels

研究概览

简要总结

Anemia is a common complication in patients with chronic kidney disease (CKD). In addition to erythropoietin deficiency, many studies have identified iron deficiency as a cause of anemia in CKD patients. Most patients with CKD are iron deficient because of: inadequate intake and absorption, gastroenteric bleeding, urinary iron loss in patient with significant proteinuria. The iron treatment is pivotal to manage anemic patients with CKD: the prescription of iron is usually oral because of practicality and safety, but often it is inevitable to administer intravenous iron because of gastroenteric malabsorption, intolerance to oral administration, irregular intake. There're few randomized controlled studies about the efficacy of oral iron versus intravenous iron in patients not on dialysis; most of them demonstrate superiority of intravenous therapy to restore iron deficiency and hemoglobin levels. A particular formulation of iron, liposomal iron has a high gastroenteric absorption and high bioavailability with lower incidence of side effects. The investigators study aims to evaluate the efficacy of treatment with liposomal oral iron compared to intravenous iron in CKD anemic patients not on dialysis in the presence of iron deficiency.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years;
  • Signed written informed consent;
  • Glomerular filtration rate (GFR) ≤ 60 mL/min (MDRD GFR calculated according to 4 variables);
  • hemoglobin ≤ 12g/dL;
  • Ferritin ≤ 100ng/mL with transferrin saturation (TSAT) ≤ 25%;
  • If erythropoiesis stimulating agents (ESA) therapy, stable dose for at least three months;

排除标准

  • Infectious diseases;
  • bleeding in the preceding six months;
  • History of malignancy tumor in the last 3 years;
  • Anemia case different from that resulting from CKD;
  • vitamin B12 and folate deficiency;
  • Surgery of any kind in the last three months;
  • systemic haematological disease;
  • Blood Transfusions, therapy with intravenous or oral iron in the last three months;
  • Severe liver disease / test positive for hepatitis C virus (HCV) and hepatitis B virus (HBV);
  • Abuse of alcohol and drugs in the preceding six months;
  • immunosuppressive therapy ;
  • Significant weight loss;
  • Pregnancy or breast-feeding.

研究组 & 干预措施

oral liposomal iron

Experimental

patients receive a dose of liposomal 30 mg/die iron (equivalent to 1 cp Sideral forte).

干预措施: Liposomal iron (Drug)

endovenous iron

Active Comparator

patients receive a total dose 1000 mg of intravenous iron gluconate divided into administrations of 125 mg diluted in 250 mL normal saline infused weekly for 3 months

干预措施: gluconate iron (Drug)

结局指标

主要结局

modification in hemoglobin levels

时间窗: 3 months

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eleonora Riccio

MD

Federico II University

研究点 (1)

Loading locations...

相似试验