Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

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

Detailed Description
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Aim of The Work: 1- Evaluation of the effect of febuxostat on endothelial dysfunction in hemodialysis patients, through detection of: Primary endpoint: • Reduction in Asymmetrical Dimethylarginine (ADMA) Secondary endpoints: Assessing the change in serum High sensitivity C-reactive protein (hsCRP) Assessing the change in serum Uric acid - The criteria for inclusion: Outpatients on maintenance hemodialysis. Age from 18-70 years old. Serum UA level 7.0 mg/dL or more. Stable clinical condition (no hospitalization in the previous 3 months) The 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. 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.

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

Conditions
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Endothelial Dysfunction, Endstage Renal Disease

Intervention / Treatment
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* Drug: Febuxostat
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I<br>This Group of Patients will receive Febuxostat Drug along with their Standard Treatment. | Drug: Febuxostat<br>* Film Coated Tablets of Donifoxate (Eva Pharma company ) 40mg administered thrice weekly post hemodialysis session<br>* Other names: Donifoxate;|
| Placebo Comparator: Group II<br>This Group of Patients will receive Placebo along with their standard Treatment. | Drug: Placebo<br>* Film Coated Tablets (Placebo) to be administered thrice weekly post hemodialysis session. same color, taste , size . Same all ingredients except Febuxostat (Active ingredient) .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 months |