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

Ain Shams University

Status and phase: Completed; Phase 1

Conditions: Carotid Intima- Media Thickness

Treatments: Drug: Febuxostat 40 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06997952

FMASU MS268/2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Case

Active Comparator group

Description:

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.

Treatment:

Drug: Febuxostat 40 mg

Control

No Intervention group

Description:

continued with their standard treatment alone