Back to resultsThe Effect of Uric Acid Decrement on Endothelial Function in Patients With Chronic Renal Failure
Primary Purpose
Hyperuricemia, Chronic Kidney Disease
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
allopurinol
Sponsored by
About this trial
This is an interventional screening trial for Hyperuricemia focused on measuring allopurinol, chronic kidney disease, endothelial dysfunction, hyperuricemia, uric acid, vascular endothelium, xanthine oxidase inhibitor
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Istanbul Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allopurinol
Arm Description
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.
Outcomes
Primary Outcome Measures
Endothelial function improvement with uric acid lowering treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT00978653
First Posted
September 14, 2009
Last Updated
September 21, 2009
Sponsor
Istanbul University
1. Study Identification
Unique Protocol Identification Number
NCT00978653
Brief Title
The Effect of Uric Acid Decrement on Endothelial Function in Patients With Chronic Renal Failure
Official Title
Prospective Study of Allopurinol Treatment That Improves Endothelial Function by Decreasing Uric Acid Levels of Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Istanbul University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia, Chronic Kidney Disease
Keywords
allopurinol, chronic kidney disease, endothelial dysfunction, hyperuricemia, uric acid, vascular endothelium, xanthine oxidase inhibitor
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allopurinol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
allopurinol
Other Intervention Name(s)
urikoliz
Intervention Description
150 mg once a day
Primary Outcome Measure Information:
Title
Endothelial function improvement with uric acid lowering treatment
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berna Yelken, MD
Organizational Affiliation
Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yasar Caliskan
Organizational Affiliation
Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alaattin Yildiz, Prof, MD
Organizational Affiliation
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Numan Gorgulu, MD
Organizational Affiliation
Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
The Effect of Uric Acid Decrement on Endothelial Function in Patients With Chronic Renal Failure
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