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

NCT06997952 | Completed Phase 1 DMC

• 1 other identifier: FMASU MS268/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Carotid Intima- Media Thickness

Outcome Measures

Primary Outcomes (1)

• slowing CKD progression

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

  3 month

Secondary Outcomes (1)

• improvement of carotid intima-media thickness

  3 month

Study Arms (2)

Case

ACTIVE COMPARATOR

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.

Drug: Febuxostat 40 mg

Control

NO INTERVENTION

continued with their standard treatment alone

Interventions

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.

Case

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt, 11111, Egypt

Location

MeSH Terms

Interventions

Febuxostat

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: May 24, 2024
• Primary Completion: August 24, 2024
• Study Completion: August 24, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: May 24, 2024, to August 24, 2024

Locations

EG (1)