Febuxostat Effect on Chronic Kidney Disease Progression And Carotid Intima-Media Thickness

Ain Shams University50 enrolled

Overview

This study aimed to evaluate the impact of febuxostat on both carotid intima-media thickness and disease progression in individuals with chronic kidney disease

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Carotid Intima- Media Thickness

Interventions

Febuxostat 40 mgDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ain Shams University

Cairo, Egypt, Egypt

Outcomes

Primary Outcomes

Change in estimated glomerular filtration rate (eGFR) from baseline to 12 weeks

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.

Time frame: 3 months

Change in proteinuria from baseline to 12 weeks

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.

Time frame: 3 months

Secondary Outcomes

Change in carotid intima-media thickness (CIMT) measured by carotid duplex from baseline to 12 weeks

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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