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

This study has been completed.
Sponsor:
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT00978653
First received: September 14, 2009
Last updated: September 21, 2009
Last verified: September 2009
  Purpose

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 Intervention
Hyperuricemia
Chronic Kidney Disease
Drug: allopurinol

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Istanbul University:

Primary Outcome Measures:
  • Endothelial function improvement with uric acid lowering treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: urikoliz

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978653

Locations
Turkey
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
  More Information

No publications provided

Responsible Party: Alaattin Yildiz, Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
ClinicalTrials.gov Identifier: NCT00978653     History of Changes
Other Study ID Numbers: 200931386
Study First Received: September 14, 2009
Last Updated: September 21, 2009
Health Authority: Turkey: Ethics Committee

Keywords provided by Istanbul University:
allopurinol
chronic kidney disease
endothelial dysfunction
hyperuricemia
uric acid
vascular endothelium
xanthine oxidase inhibitor

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Hyperuricemia
Urologic Diseases
Renal Insufficiency
Pathologic Processes
Allopurinol
Uric Acid
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014