Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.
|ClinicalTrials.gov Identifier: NCT02866214|
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : January 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Endothelial Dysfunction Endstage Renal Disease||Drug: Febuxostat Drug: Placebo||Phase 2 Phase 3|
Aim of The Work:
1- Evaluation of the effect of febuxostat on endothelial dysfunction in hemodialysis patients, through detection of:
• Reduction in Asymmetrical Dimethylarginine (ADMA)
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Evaluation of the Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.|
|Study Start Date :||August 2016|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Experimental: Group I
This Group of Patients will receive Febuxostat Drug along with their Standard Treatment.
Film Coated Tablets of Donifoxate (Eva Pharma company ) 40mg administered thrice weekly post hemodialysis session
Other Name: Donifoxate
Placebo Comparator: Group II
This Group of Patients will receive Placebo along with their standard Treatment.
Film Coated Tablets (Placebo) to be administered thrice weekly post hemodialysis session.
same color, taste , size . Same all ingredients except Febuxostat (Active ingredient) .
- 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.
- Uric Acid , physiological parameter [ Time Frame: 2 months ]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.
- High sensitivity C-reactive protein physiological marker [ Time Frame: 2 months ]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.