Carotid Intima- Media Thickness
Conditions
Brief summary
This study aimed to evaluate the impact of febuxostat on both carotid intima-media thickness and disease progression in individuals with chronic kidney disease
Detailed description
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.
Interventions
DRUGFebuxostat 40 mg
Febuxostat will be given daily for 12 weeks The prescribed dosage was 40 mg taken once daily, self-administered by the patients in addition to their standard treatment.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in estimated glomerular filtration rate (eGFR) from baseline to 12 weeks | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in carotid intima-media thickness (CIMT) measured by carotid duplex from baseline to 12 weeks | 3 months | Change in carotid intima-media thickness (CIMT), assessed by carotid duplex imaging, from baseline to 12 weeks following administration of febuxostat compared with the control group. CIMT will be measured in millimetres (mm) using a standardized carotid duplex protocol. |
Countries
Egypt
Outcome results
None listed