The Potential Nephro-protective Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Serum Creatinine Level
研究概览
简要总结
The aim of this study is to evaluate the effect of administration of folic acid and /or pentoxifylline on patients with chronic kidney disease (CKD).
详细描述
Chronic kidney disease (CKD) is a worldwide public health problem, with adverse outcomes of kidney failure, cardiovascular disease (CVD), and premature death. Chronic kidney disease (CKD) affects between 8% and 16% of the population worldwide.Defined by a glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m2, albuminuria of at least 30 mg per 24 hours, or markers of kidney damage (eg, hematuria or structural abnormalities such as polycystic or dysplastic kidneys) persisting for more than 3 months.That nutrient loss because of diet restriction and chronic inflammation contributed by CKD itself may stimulate progression in advanced chronic kidney disease. Folic acid was then selected as a nutrient intervention. In the mean time, pentoxifylline was well studied in this field for its anti-inflammatory effects.Pentoxifylline (PTF) appears to improve circulation through its ability to alter erythrocyte deformability and enhances capillary microcirculation. This hemorheological property and the potential capacity in decreasing intraglomerular pressure has led to recent interest in PTF as a therapeutic agent in patients with kidney disease. In addition to these properties, PTF has an effect on inflammation, oxidative stress and endothelial function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have chronic kidney disease(CKD) stages 3-5
- •Aged between18 - 60 years old.
- •Both sexes.
- •Stable clinical condition defined as no hospitalizations or cardiovascular events within the 3 months before screening
- •Stable renal function (baseline serum creatinine had to have not increased by 50% in the 3 months before screening)
- •No changes in concomitant medication during the study.
- •Patients who accept to participate in the study.
排除标准
- •Pregnant women
- •Current use of PTF
- •Contraindication to use of PTF drug: history of PTF or theophylline allergy, history of severe retinal hemorrhage or recent cerebral hemorrhage
- •Those with active infections or inflammatory diseases or HIV infection
- •Those with chronic liver disease .
- •Patients who had received immunosuppressive therapy
- •Non-compliant patients
研究组 & 干预措施
folic acid Group
20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.
干预措施: folic acid (Drug)
Pentoxifylline Group
20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.
干预措施: Pentoxifylline 400 MG (Drug)
folic acid and pentoxifylline Group
20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months
干预措施: combination of Pentoxifylline 400 MG and Folic Acid (Drug)
结局指标
主要结局
Change in Serum Creatinine Level
时间窗: Baseline, 6 months
Change was calculated as the value at 6 months minus the value at baseline.
次要结局
- Serum Ferritin in ng/ml(6 months)
研究者
Amira Reda Muhammad Galal
Principal investigator
Al-Azhar University