Exploring the Potential Effect of Pentoxifylline in Mitigating Vascular Calcification in Chronic Kidney Disease Patients
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Change in Agatston Coronary Artery Calcification Score from Baseline to 6 Months
研究概览
简要总结
This study is research to find out if the drug pentoxifylline can help prevent or lessen the problem of blood vessel hardening (vascular calcification) in people with chronic kidney disease (CKD). People with CKD are at higher risk for heart problems and blood vessel hardening. Vascular calcification happens when calcium builds up in the blood vessels, making them stiff. Pentoxifylline is a drug that might have helpful effects that could reduce this hardening. In this study, some CKD patients will receive pentoxifylline in addition to their usual medications, while others will only receive their usual medications. The researchers will then compare the amount of vascular calcification in both groups over 6 months to see if pentoxifylline makes a difference. The goal is to learn if pentoxifylline could be a new way to protect the blood vessels of people with chronic kidney disease.
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
- •Estimated Glomerular Filtration Rate (eGFR) less than 60 ml/min/1.73 m² and greater than or equal to 15 ml/min/1.73 m².
- •Adult patients, age 18 years or older.
- •Diagnosis of Chronic Kidney Disease (CKD).
- •Willing and able to provide informed consent.
排除标准
- •Patients currently undergoing regular hemodialysis.
- •History of kidney transplantation or are kidney transplant recipients.
- •Pregnant females.
- •Patients with a history of coronary artery bypass grafting (CABG).
- •Known allergy or contraindication to pentoxifylline.
- •Inability to comply with study procedures or attend follow-up visits.
研究组 & 干预措施
Pentoxifylline Arm
Participants in this arm will receive Pentoxifylline 400 mg twice daily orally with food, in addition to their conventional medications for chronic kidney disease (CKD). Pentoxifylline treatment will be administered for 6 months, concurrent with the study duration. Conventional medications will continue as prescribed by their treating physician and will be consistent with standard of care for CKD.
干预措施: Pentoxifylline 400 MG Oral Tablet (Drug)
Conventional Medication Group
Participants in this arm will receive conventional medications for chronic kidney disease (CKD) only. They will not receive Pentoxifylline. Conventional medications will be administered as prescribed by their treating physician and will be consistent with standard of care for CKD. This arm serves as the control group to compare against the Pentoxifylline arm in evaluating the potential effect of Pentoxifylline on vascular calcification.
干预措施: Conventional Medications for Chronic Kidney Disease (Other)
结局指标
主要结局
Change in Agatston Coronary Artery Calcification Score from Baseline to 6 Months
时间窗: 6 Months
The primary outcome measure is the change in coronary artery calcification as assessed by the Agatston score, measured from baseline to 6 months after the start of the intervention. Coronary artery calcification will be quantified using computed tomography (CT) scans and analyzed using the Agatston method. A higher Agatston score indicates a greater degree of coronary artery calcification. The change will be calculated as the difference between the Agatston score at 6 months and the Agatston score at baseline.
次要结局
- Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline to 6 Months(6 Months)
研究者
Dina Massoud Gaber
Resident in Nephrology
Mansoura University