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

NCT ID: NCT06997952

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-24

Study Completion Date

2024-08-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carotid Intima- Media Thickness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Case

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.

Group Type ACTIVE_COMPARATOR

Febuxostat 40 mg

Intervention Type 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.

Control

continued with their standard treatment alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Febuxostat 40 mg

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain Shams University

Cairo, Egypt, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FMASU MS268/2024

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Renal Impairment Study for PF-04965842
NCT03660241 COMPLETED PHASE1
A Study of CCX140-B in Subjects With FSGS
NCT03536754 COMPLETED PHASE2