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

September 21, 2009 updated by: Istanbul University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34390
        • Istanbul Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial function improvement with uric acid lowering treatment
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

September 14, 2009

First Submitted That Met QC Criteria

September 16, 2009

First Posted (ESTIMATE)

September 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 22, 2009

Last Update Submitted That Met QC Criteria

September 21, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200931386

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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