The Effects of a Single Intravenous Iron Upon Vascular Endothelium and Some Parameters of Oxidative Stress in Patients With Non-dialysis Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect on endothelial function
研究概览
简要总结
The purpose of this study is to investigate the effects of acute intravenous iron administration on the endothelial function in non-dialysis Chronic Kidney Disease stages G3-G5 patients with anemia and iron deficiency, in relation to changes in oxidative and nitrosative status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Chronic kidney disease stages G3-G5 (defined according to KDIGO criteria);
- •Anemia (defined according to KDIGO criteria) and iron deficiency defined as serum ferritin < 100 ng/mL and/or TSAT < 20% (KDIGO).
排除标准
- •contraindications of intravenous iron therapy: iron allergy, active infection, hemochromatosis, iron overload (serum ferritin > 500 ng/mL and/or transferrin saturation > 50%);
- •treatment with iron and erythropoiesis-stimulating agents (at the time of recruitment and 6 months previously);
- •active smoker status;
- •antioxidant food supplements treatment in the last 3 months;
- •clinically manifest bleeding;
- •another cause of anemia (hemoglobinopathies, vitamin B12 and/or folic acid deficiency suggested by the megaloblastic peripheral blood smears's appearance, multiple myeloma and other paraproteinemias);
- •severe anemia (Hb < 7 g/dl);
- •baseline FMD < 7% (the existence of atherosclerosis which limits arterial reactivity);
- •cancer (currently or in the past 6 months);
- •hepatopathies (increased serum transaminases ≥ 3 x normal value) or hepatic impairment ≥ grade Child B;
- •autoimmune disorders or significant inflammation (as defined by C-reactive protein > 5 mg/L);
- •pregnancy or lactation;
- •participation in other clinical trials over the upast 3 months;
- •patient unwillingness.
研究组 & 干预措施
Ferric carboxymaltose
Intervention: 1000 mg Ferinject in 250 mL 0.9%NaCl, representing medication in study infusion, over 30 minutes.
干预措施: Ferinject (Drug)
Placebo
Intervention: 250 mL Sodium Chloride 0.9% Intravenous Solution, representing control infusion, over 30 minutes.
干预措施: Sodium Chloride 0.9% Intravenous Solution (Drug)
Placebo
Intervention: 250 mL Sodium Chloride 0.9% Intravenous Solution, representing control infusion, over 30 minutes.
干预措施: Ferinject (Drug)
Ferric carboxymaltose
Intervention: 1000 mg Ferinject in 250 mL 0.9%NaCl, representing medication in study infusion, over 30 minutes.
干预措施: Sodium Chloride 0.9% Intravenous Solution (Drug)
结局指标
主要结局
Effect on endothelial function
时间窗: through study completion, an average of 1 year
Description of the endothelial function variation (changing in flow-mediated vasodilatation (FMD) endothelium-dependent, and also in serum sICAM-1, sVCAM-1 and nitric oxide metabolism parameters ) after administration of a single intravenous dose of iron versus a control solution, in CKD non-dialysis patients.
Oxidative stress
时间窗: through study completion, an average of 1 year
Description of some free radicals production's markers (lipid peroxidation and carbonyl stress assessment) and in antioxidant system in plasma markers variation after administration of a single intravenous iron dose versus a control solution, in non-dialysis CKD subjects.
次要结局
- Correlation between endothelial dysfunction and oxidative stress markers(through study completion, an average of 1 year)
研究者
Ana-Maria Mehedinti
Teaching Assistent
Carol Davila University of Medicine and Pharmacy