Evaluation of the Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

Ain Shams University0 sites57 target enrollmentAugust 2016

ConditionsEndothelial Dysfunction Endstage Renal Disease

InterventionsFebuxostat Placebo

DrugsFebuxostat Placebo

Overview

Phase: Phase 2
Intervention: Febuxostat
Conditions: Endothelial Dysfunction
Sponsor: Ain Shams University
Enrollment: 57
Primary Endpoint: Asymmetric Dimethylarginine physiological marker
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The Purpose of this study is to determine if the Febuxostat has an effect on endothelial dysfunction on hemodialysis patients.

Detailed Description

Aim of The Work: 1- Evaluation of the effect of febuxostat on endothelial dysfunction in hemodialysis patients, through detection of: 1. Primary endpoint: • Reduction in Asymmetrical Dimethylarginine (ADMA) 2. Secondary endpoints: * Assessing the change in serum High sensitivity C-reactive protein (hsCRP) * Assessing the change in serum Uric acid - The criteria for inclusion: 1. Outpatients on maintenance hemodialysis. 2. Age from 18-70 years old. 3. Serum UA level 7.0 mg/dL or more. 4. Stable clinical condition (no hospitalization in the previous 3 months) The exclusion criteria: 1. Current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat) 2. History of hypersensitivity to febuxostat. 3. Current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol. 4. Participant in an another clinical trial within the past 4 weeks. 5. Judged to be unsuitable as a subject by the attending physician. After two months , the patient will be reassessed regarding: A. ADMA serum level. B. Change in serum hsCRP. C. Change in serum Uric acid level.

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

October 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ain Shams University

Responsible Party

Principal Investigator

Mona AlShahawey AlSayed Ghazy

Administrator at clinical pharmacy department .

Ain Shams University

Eligibility Criteria

Inclusion Criteria

•Outpatients on maintenance hemodialysis.
•Age from 18-70 years old.
•Serum Uric Acid level 7.0 mg/dL or more.
•Stable clinical condition (no hospitalization in the previous 3 months)
•Informed consent in accordance with the Declaration of Helsinki.

Exclusion Criteria

•Current urate-lowering therapy. (allopurinol, probenecid, bucolome, febuxostat)
•History of hypersensitivity to febuxostat.
•Current treatment with mercaptopurine, azathioprine, pyrazinamide, or ethambutol.
•Participant in an another clinical trial within the past 4 weeks.
•Judged to be unsuitable as a subject by the attending physician

Arms & Interventions

Group I

This Group of Patients will receive Febuxostat Drug along with their Standard Treatment.

Intervention: Febuxostat

Group II

This Group of Patients will receive Placebo along with their standard Treatment.

Intervention: Placebo

Outcomes

Primary Outcomes

Asymmetric Dimethylarginine physiological marker

Time Frame: 2 months

Asymmetric dimethylarginine (ADMA) physiological marker for assessing endothelial dysfunction will be measured for all the anticipated 50 patients at time zero and by the end of the two months.