NCT00978653

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
Last Updated

September 22, 2009

Status Verified

September 1, 2009

Enrollment Period

11 months

First QC Date

September 14, 2009

Last Update Submit

September 21, 2009

Conditions

HyperuricemiaChronic Kidney Disease

Keywords

allopurinolchronic kidney diseaseendothelial dysfunctionhyperuricemiauric acidvascular endotheliumxanthine oxidase inhibitor

Outcome Measures

Primary Outcomes (1)

  • Endothelial function improvement with uric acid lowering treatment

    1 year

Study Arms (1)

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.

Drug: allopurinol

Interventions

allopurinolDRUG

150 mg once a day

Also known as: urikoliz
Allopurinol

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Faculty of Medicine

Istanbul, 34390, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HyperuricemiaRenal Insufficiency, Chronic

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Alaattin Yildiz, Prof, MD

    Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University

    STUDY DIRECTOR

  • Numan Gorgulu, MD

    Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine, Istanbul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2009

First Posted

September 17, 2009

Study Start

April 1, 2008

Primary Completion

March 1, 2009

Study Completion

May 1, 2009

Last Updated

September 22, 2009

Record last verified: 2009-09

Locations

TU(1)