HyperuricemiaNCT00978653
The Effect of Uric Acid Decrement on Endothelial Function in Patients With Chronic Renal Failure
A study testing allopurinol in people with Hyperuricemia and Chronic Kidney Disease, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In this prospective study, the investigators aimed to evaluate the effects of improved hyperuricemia, a minor cardiovascular risk factor, on endothelial dysfunction in patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hyperuricemia, Chronic Kidney Disease
- What is being tested?
- allopurinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2008to May 2009
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Laboratory finding of hyperuricemia
- Patients between ages of 18 and 60 years
- Non-diabetic patients
- Creatinine clearance values between 20 and 60 mL/min/1.73 m2
Who cannot join
- Low (< 20 ml/min/1.73 m2) creatinine clearance,
- Patients with diabetes mellitus, ischemic heart disease, acute coronary syndrome, congestive heart failure (CHF) (New York Heart Association class II or greater), valvular heart disease and a history of cerebral infarction or transient ischemic attack.
- Patients taking urate lowering medication (allopurinol and probenecid)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Allopurinol Treatment That Improves Endothelial Function by Decreasing Uric Acid Levels of Patients With Chronic Kidney Disease
In this prospective study, the investigators aimed to evaluate the effects of improved hyperuricemia, a minor cardiovascular risk factor, on endothelial dysfunction in patients with chronic kidney disease.
Read the detailed description
Endothelial dysfunction (ED) is a key event in the development of atherosclerotic cardiovascular disease observed in patients with chronic kidney disease (CKD). Experimental models have shown that hyperuricemia causes hypertension and renin angiotensin system activation. In this prospective study, the investigators aimed to evaluate the effects of improved hyperuricemia, a minor cardiovascular risk factor, on ED in patients with CKD.
- Conditions
- Hyperuricemia, Chronic Kidney Disease
- Being tested
- allopurinol
- Keywords
- allopurinol, chronic kidney disease, endothelial dysfunction, hyperuricemia, uric acid, vascular endothelium, xanthine oxidase inhibitor
- Medical subject headings
- Hyperuricemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allopurinolDrug
Also called urikoliz
150 mg once a day
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | Experimental | Hyperuricemic (uric acid (UA)>7 mg/dL), nondiabetic CKD patients without any comorbidity, age<60 years with creatinine clearance (CrCl) between 20 and 60ml/min were evaluated. Receives: Drug: allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function improvement with uric acid lowering treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- More trials run by Istanbul 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Investigators
- Berna Yelken, MD, Principal investigator, Division of Nephrology, Istanbul Faculty of Medicine, Istanbul UniversityYasar Caliskan, Principal investigator, Division of Nephrology, Istanbul Faculty of Medicine, Istanbul UniversityAlaattin Yildiz, Prof, MD, Study director, Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul UniversityNuman Gorgulu, MD, Principal investigator, Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978653
- Sponsor's protocol ID
- 200931386
- Status last verified
- Sep 2009
- First submitted
- 14 Sep 2009
- Last updated
- 22 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Allopurinol Treatment That Improves Endothelial Function by Decreasing Uric Acid Levels of Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00978653
- Acronym / sponsor ID
- 200931386
- Conditions
- Hyperuricemia, Chronic Kidney Disease
- Keywords
- allopurinol, chronic kidney disease, endothelial dysfunction, hyperuricemia, uric acid, vascular endothelium, xanthine oxidase inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 17 Sep 2009 (estimated)
- 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.
In this prospective study, the investigators aimed to evaluate the effects of improved hyperuricemia, a minor cardiovascular risk factor, on endothelial dysfunction in patients with chronic kidney disease.
Detailed description
Endothelial dysfunction (ED) is a key event in the development of atherosclerotic cardiovascular disease observed in patients with chronic kidney disease (CKD). Experimental models have shown that hyperuricemia causes hypertension and renin angiotensin system activation. In this prospective study, the investigators aimed to evaluate the effects of improved hyperuricemia, a minor cardiovascular risk factor, on ED in patients with CKD.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Experimental | Drug: allopurinolHyperuricemic (uric acid (UA)>7 mg/dL), nondiabetic CKD patients without any comorbidity, age<60 years with creatinine clearance (CrCl) between 20 and 60ml/min were evaluated. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Laboratory finding of hyperuricemia
- Patients between ages of 18 and 60 years
- Non-diabetic patients
- Creatinine clearance values between 20 and 60 mL/min/1.73 m2
Key exclusion criteria (3 listed)
- Low (< 20 ml/min/1.73 m2) creatinine clearance,
- Patients with diabetes mellitus, ischemic heart disease, acute coronary syndrome, congestive heart failure (CHF) (New York Heart Association class II or greater), valvular heart disease and a history of cerebral infarction or transient ischemic attack.
- Patients taking urate lowering medication (allopurinol and probenecid)
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 |
|---|---|---|
| allopurinolAlso: urikoliz150 mg once a day | Drug | Allopurinol |
Primary outcome
Endothelial function improvement with uric acid lowering treatment
Time frame: 1 year
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 22 Sep 2009.
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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.
Berna Yelken, MD principal investigator
Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Yasar Caliskan principal investigator
Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Alaattin Yildiz, Prof, MD study director
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing allopurinol in people with Hyperuricemia and Chronic Kidney Disease, run by Istanbul University at 1 site in Turkey (Türkiye).
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 3 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 22 Sep 2009. 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 Turkey (Türkiye). 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.
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?
Endothelial function improvement with uric acid lowering treatment (time frame: 1 year). 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 22 Sep 2009.