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Completed

NCT Number: NCT06997952

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ain Shams University

Cairo, Egypt, 11111

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Febuxostat 40 mg

Drug

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.

Primary outcomes

  1. slowing CKD progression

    Time frame: 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 outcomes

  1. improvement of carotid intima-media thickness

    Time frame: 3 month

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Impact of Febuxostat on Disease Progression and Carotid Intima-Media Thickness in Patients With Chronic Kidney Disease

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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