Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

Ain Shams University57 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Endothelial Dysfunction Endstage Renal Disease

Interventions

FebuxostatDRUG

Film Coated Tablets of Donifoxate (Eva Pharma company ) 40mg administered thrice weekly post hemodialysis session

PlaceboDRUG

Film Coated Tablets (Placebo) to be administered thrice weekly post hemodialysis session. same color, taste , size . Same all ingredients except Febuxostat (Active ingredient) .

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Asymmetric Dimethylarginine physiological marker

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.

Time frame: 2 months

Secondary Outcomes

Uric Acid , physiological parameter

Uric acid,physiological parameter for assessing the grade of hyperuricemia will be measured for all the anticipated 50 patients at time zero and by the end of the two months.

Time frame: 2 months

High sensitivity C-reactive protein physiological marker

HsCRP , physiological marker for assessing inflammation will be measured for all the anticipated 50 patients at time zero and by the end of the two months.

Time frame: 2 months

Data from ClinicalTrials.gov

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