Carotid Intima- Media ThicknessPhase 1NCT06997952
Febuxostat Effect on Chronic Kidney Disease Progression And Carotid Intima-Media Thickness
A Phase 1 study testing Febuxostat 40 mg in people with Carotid Intima- Media Thickness, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Intima- Media Thickness
- What is being tested?
- Febuxostat 40 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 24 May 2024to 24 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Patients with liver disease.
- Patients receiving mercaptopurine, theophylline and azathioprine.
- Patients on steroids or other immunosuppressive treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Febuxostat on Disease Progression and Carotid Intima-Media Thickness in Patients With Chronic Kidney Disease
This study aimed to evaluate the impact of febuxostat on both carotid intima-media thickness and disease progression in individuals with chronic kidney disease
Read the 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.
- Conditions
- Carotid Intima- Media Thickness
- Being tested
- Febuxostat 40 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Febuxostat 40 mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Febuxostat 40 mg |
| Control | No intervention | continued with their standard treatment alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in estimated glomerular filtration rate (eGFR) from baseline to 12 weeks
Change in estimated glomerular filtration rate (eGFR), calculated using the CKD-EPI equation and expressed as mL/min/1.73 m², from baseline to 12 weeks following administration of febuxostat compared with the control group.
Measured: 3 months
Change in proteinuria from baseline to 12 weeks
Change in proteinuria, assessed by the urine protein-to-creatinine ratio (Pr/Cr ratio, mg/g), from baseline to 12 weeks following administration of febuxostat compared with the control group.
Measured: 3 months
Secondary outcomes (1)
Change in carotid intima-media thickness (CIMT) measured by carotid duplex from baseline to 12 weeks
Change in carotid intima-media thickness (CIMT), assessed by carotid duplex imaging, from baseline to 12 weeks following administration of febuxostat compared with the control group. CIMT will be measured in millimetres (mm) using a standardized carotid duplex protocol.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start24 May 2024
- Primary completion24 Aug 2024
- Study completion24 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Intima- Media ThicknessStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997952
- Sponsor's protocol ID
- FMASU MS268/2024
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Febuxostat on Disease Progression and Carotid Intima-Media Thickness in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06997952
- Acronym / sponsor ID
- FMASU MS268/2024
- Conditions
- Carotid Intima- Media Thickness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 24 May 2024 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 24 Aug 2024 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | Active comparator | Drug: Febuxostat 40 mgReceived 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. |
| Control | No intervention | –continued with their standard treatment alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Comprised active infections.
- Acute kidney injury.
- Active and advanced malignancy.
- History of hypersensitivity to febuxostat.
- Women who are taking oral contraceptives, pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Febuxostat 40 mgFebuxostat 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. | Drug | Case |
Primary outcome
Change in estimated glomerular filtration rate (eGFR) from baseline to 12 weeks
Time frame: 3 months
Change in estimated glomerular filtration rate (eGFR), calculated using the CKD-EPI equation and expressed as mL/min/1.73 m², from baseline to 12 weeks following administration of febuxostat compared with the control group.
Change in proteinuria from baseline to 12 weeks
Time frame: 3 months
Change in proteinuria, assessed by the urine protein-to-creatinine ratio (Pr/Cr ratio, mg/g), from baseline to 12 weeks following administration of febuxostat compared with the control group.
1 secondary outcome
Change in carotid intima-media thickness (CIMT) measured by carotid duplex from baseline to 12 weeks
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Febuxostat 40 mg in people with Carotid Intima- Media Thickness, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in estimated glomerular filtration rate (eGFR) from baseline to 12 weeks (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.