Impact of Febuxostat on Disease Progression and Carotid Intima-Media Thickness in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in estimated glomerular filtration rate (eGFR) from baseline to 12 weeks
研究概览
简要总结
This study aimed to evaluate the impact of febuxostat on both carotid intima-media thickness and disease progression in individuals with chronic kidney disease
详细描述
For all participants, comprehensive data collection was performed, encompassing detailed medical histories including patients' clinical and demographic characteristics (age, gender, BMI, associated comorbidities as HTN, and DM, etiology of CKD.) Laboratory investigations were conducted at baseline and after a three-month follow-up period. These investigations included: serum uric acid., creatinine, blood urea nitrogen, calcium, phosphorus., albumin., magnesium, intact parathyroid hormone (iPTH), lipid profile (cholesterol, triglycerides, LDL, HDL), urine protein to creatinine ratio. Radiological investigations: Carotid artery duplex (medial wall thickness) was also conducted at baseline and after a three-month follow-up period. Thickening of the artery wall is a hallmark of atherosclerosis and vascular calcification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Age of 18 years or older
- •CKD stages III to IV
- •Asymptomatic hyper uricemia
- •Stable dose of all medications including ACEIs or ARBs for blood pressure control at least three months before enrolling
排除标准
- •Comprised active infections.
- •Acute kidney injury.
- •Active and advanced malignancy.
- •History of hypersensitivity to febuxostat.
- •Women who are taking oral contraceptives, pregnant or lactating
- •Patients with established cardiovascular disease.
- •Patients with liver disease.
- •Patients receiving mercaptopurine, theophylline and azathioprine.
- •Patients on steroids or other immunosuppressive treatment.
研究组 & 干预措施
Control
continued with their standard treatment alone
Case
Received febuxostat daily for 12 weeks in addition to their standard treatment. The prescribed dosage was 40 mg taken once daily, self-administered by the patients.
干预措施: Febuxostat 40 mg (Drug)
结局指标
主要结局
Change in estimated glomerular filtration rate (eGFR) from baseline to 12 weeks
时间窗: 3 months
Change in estimated glomerular filtration rate (eGFR), calculated using the CKD-EPI equation and expressed as mL/min/1.73 m², from baseline to 12 weeks following administration of febuxostat compared with the control group.
Change in proteinuria from baseline to 12 weeks
时间窗: 3 months
Change in proteinuria, assessed by the urine protein-to-creatinine ratio (Pr/Cr ratio, mg/g), from baseline to 12 weeks following administration of febuxostat compared with the control group.
次要结局
- Change in carotid intima-media thickness (CIMT) measured by carotid duplex from baseline to 12 weeks(3 months)