The Effect of Uric Acid Decrement on Endothelial Function in Patients With Chronic Renal Failure

Sponsor

Istanbul University (Other)

Overall Status

Completed

CT.gov ID

NCT00978653

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperuricemia Chronic Kidney Disease	Drug: allopurinol	N/A

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

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Prospective Study of Allopurinol Treatment That Improves Endothelial Function by Decreasing Uric Acid Levels of Patients With Chronic Kidney Disease

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Allopurinol 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.	Drug: allopurinol 150 mg once a day Other Names: urikoliz

Arm

Intervention/Treatment

Experimental: Allopurinol

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.

Drug: allopurinol

150 mg once a day

Other Names:

urikoliz

Outcome Measures

Primary Outcome Measures

Endothelial function improvement with uric acid lowering treatment [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Faculty of Medicine	Istanbul		Turkey	34390

Sponsors and Collaborators

Istanbul University

Investigators

Principal Investigator: Berna Yelken, MD, Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Principal Investigator: Yasar Caliskan, Division of Nephrology, Istanbul Faculty of Medicine, Istanbul University
Study Director: Alaattin Yildiz, Prof, MD, Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University
Principal Investigator: Numan Gorgulu, MD, Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University