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

Phase 1

Completed

• Conditions: Carotid Intima- Media Thickness
• Interventions: Drug: Febuxostat 40 mg

• Registration Number: NCT06997952
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2024-05-24
• Primary Completion: 2024-08-24
• Study Completion: 2024-08-24
• Status Verified: 2025-05
• Study First Submitted: 2025-05-22
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case	Febuxostat 40 mg	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.

Primary Outcome Measures

Name	Time	Method
slowing CKD progression	3 month	improvement of eGFR and proteinuria after 12 weeks of administration of febuxostat (slowing CKD progression), compared with that of the control group.

Secondary Outcome Measures

Name	Time	Method
improvement of carotid intima-media thickness	3 month	improvement of carotid intima-media thickness after after 12 weeks of administration of febuxostat ,compared with that of the control group.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt