Evaluation Of The Impact Of A New Synthetic Vitamin E-Bonded Membrane On The Anemia And Oxidative Stress In End-Stage Renal Disease (ESRD) Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary outcome measure will be the ESA resistance index, a combined variable calculated by dividing the weekly ESA dose by haemoglobin level and end-dialysis body weight.
研究概览
简要总结
The main purpose of this longitudinal study is to point out the effect of VitabranE on the ESA resistance and on the anemia observed in HD patients undergoing EPO maintenance therapy.
As a secondary purpose we will consider the effect of VitabranE on inflammation and oxidative stress parameters as a function of the changes observed in the anemia parameters.
详细描述
Aim
The aim of this pilot randomized study is to verify whether the addition of vitamin E alpha-tocopherol to the blood-side layer of a synthetic polysulfone dialyser membrane has a clinical advantage in terms of ESA responsiveness and, consequently, the anemic status of hemodialysed patients.
Patients
Patients of both genders aged more than 18 years will be considered eligible for the study if they had been receiving bicarbonate hemodialysis treatment for at least six months and stable ESA therapy for at least three months, and had adequate iron stores (ferritin levels >200 ng/ml and transferrin saturation >20%). Patients with haemoglobinopathies, sickle cell anemia, thalassemia or malignancies will be excluded, as were those who had experienced infection, vascular access thrombosis, stroke, myocardial infarction, heavy blood loss, major surgery or blood transfusion in the previous three months.
Study design
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
- 否
入选标准
- •Male and female patients, aged ≥ 18, stabilized on BHD for at least 6 months.
- •Clinical stability during the last 3 months.
- •Serum Ferritin > 200 mg/L and Transferrin saturation >30%.
- •Maintenance therapy with epoetin alfa/beta or darbepoetin alfa.
排除标准
- •One of the following condition in the last 3 months :
- •acute infection
- •vascular access thrombosis
- •ictus cerebri
- •myocardial stroke
- •haemorrhage
- •major surgery
- •haemo-transfusion
- •Haemoglobinopaty, sickle cell anemia, familial erythroblastic anemia and any other haematological disorder interfering with the aim of the study
- •Participation to other studies or use of EPO analogues not yet commercialized
- •pharmacological dosage administration of antioxidant supplements
研究组 & 干预措施
1
VitabranE ViE: Vitamin E-bonded polysulfone dialyzer
干预措施: VitabranE ViE (Device)
2
APS-U (Asahi Polysulfone APS): Polysulfone dialyzer
结局指标
主要结局
The primary outcome measure will be the ESA resistance index, a combined variable calculated by dividing the weekly ESA dose by haemoglobin level and end-dialysis body weight.
时间窗: every other month
次要结局
- Inflammatory status (CRP and IL-6) and oxidative stress markers (Vitamin E levels, TAC, Protein carbonyls and AOPP, AGEs).(every other month)
研究者
Simeone Andrulli, MD
Simeone Andrulli, MD
A. Manzoni Hospital