Impact of Pentoxifylline Administration on the Modulation of Hyporesponsiveness to Erythropoietin Stimulating Agents in Hemodialysis Patients
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 46
- 主要终点
- safety & tolerability of pentoxifylline ( frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline).
研究概览
简要总结
The aim of the study is to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients
详细描述
this is a prospective, randomized, controlled study to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients by determining several outcomes from the intervention and control groups at the end of the study.These outcomes include;the difference in hemoglobin and hematocrit concentration , the difference in inflammatory markers tumor necrosis factor Alpha (TNF-α), interleukin-1 Beta (IL-1β),the difference in the dosage of erythropoiesis stimulating agents ,and The erythropoietin stimulating agents (ESA) resistance index (ERI).
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
- •Adults (18 years or over).
- •Stable hemodialysis >6 months.
- •Regular haemodialysis (3 times/ week).
- •ESA resistant anemia (Hb <10 mg/dl for 6 mo.).
- •ESA dose of >8000 IU/wk.
排除标准
- •Inadequate hemodialysis.
- •Hyperparathyroidism (PTH>800 pg/l).
- •Known hypersensitivity to, or intolerance of Pentoxifylline.
- •Absolute or functional iron deficiency (ferritin < 100 μg/L and/or transferrin saturation < 20%).
- •Presence of systemic haematological disease (including antibody-mediated pure red cell aplasia) or known haemoglobinopathy.
- •Major surgery, infection, inflammatory diseases, acute myocardial infarction or malignancy within the last 3 months.
- •Patients with chronic liver disease and patients who had received immunosuppressive therapy.
研究组 & 干预措施
test
23 patients will receive the intervention drug Pentoxifylline (Trental 400 milligram(MG) Extended Release Oral Tablet) twice daily in addition their usual dose of erythropoietin stimulating agents and their routine treatment.
干预措施: Trental 400 MG Extended Release Oral Tablet (Drug)
结局指标
主要结局
safety & tolerability of pentoxifylline ( frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline).
时间窗: up to 6 months post baseline
Patients will be evaluated regularly for frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline
The difference in hemoglobin and hematocrit concentration between the intervention and control groups at the end of the study
时间窗: up to 6 months post baseline
Patients will be evaluated regularly every month for hemoglobin concentration
次要结局
- Difference in the dosage of erythropoiesis stimulating agents.(up to 6 months post baseline)
- The ESA ( erythropoiesis stimulating agents)resistance index (ERI).(up to 6 months post baseline)
- Inflammatory markers TNF-a, IL-1β.(up to 6 months post baseline)
研究者
Radwa Mohamed Elmetwaly
Post grad
Ain Shams University