Effect of Pentoxifylline on Anemia in Hemodialysis Patients: Role of Hypoxia Inducible Factor-2 Alpha
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Variation in ESA resistance index (ESA Dose/kg/Week/Hb)
研究概览
简要总结
The primary goal of this clinical trial is to evaluate the promoting effect of pentoxifylline on anemia correction in hemodialysis patients, and involvement of the hypoxia-inducible factor-2 alpha. While, the secondary aim is to evaluate the effect of pentoxifylline on inflammation, hepcidin and other markers of iron homeostasis in these patients. Participants in this trial will be selected to be age and sex ratio matched and will be randomly assigned into two groups. Patients in group I will receive their regular doses of erythropoietin stimulating agents and other routine treatments plus 400 mg pentoxifylline tablets twice daily with meals for 6 months. While, patients in group II will receive their regular doses of erythropoietin stimulating agents and other routine treatments.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes of HD patients
- •Age >20 years
- •Patients who have adequate hemodialysis for at least 6 months
- •Hb level ≤ 10.5 g/dl
排除标准
- •Recently dialyzed patients (less than 6 months)
- •Patients with known sensitivity to theophylline or other xanthine derivatives
- •Severe iron deficiency with serum ferritin < 100 µg/dL and/or TSAT < 20%
- •Planning for pregnancy, pregnancy, or lactation
- •Patients with severe liver disease or other organ failure
- •Previous renal transplantation, noncompliance with medication or HD prescription, or inability to oral drug administration
- •Malignancy within last 3 months
研究组 & 干预措施
Group I
干预措施: pentoxifylline (Drug)
结局指标
主要结局
Variation in ESA resistance index (ESA Dose/kg/Week/Hb)
时间窗: 6 months
Variation in Hypoxia inducible factor-2 alpha (HIF-2α) levels
时间窗: 6 months
Variation in Transforming growth factor β1 (TGF-β1) levels
时间窗: 6 months
Variation in erythropoietin stimulating agents' (ESAs) doses
时间窗: 6 months
Variation in Hemoglobin (Hb) levels
时间窗: 6 months
次要结局
- Variation in hepcidin hormone levels(6 months)
- Variation in different parameters for iron status evaluation(6 months)
- Variation in different inflammatory markers levels(6 months)
研究者
hadeer zakaria
PhD student in Clinical Pharmacy and Pharmacy Practice Department
Alexandria University