NCT02866214

Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Endothelial Dysfunction
• Endstage Renal Disease

Interventions

Type	Name	Description
DRUG	Febuxostat	Film Coated Tablets of Donifoxate (Eva Pharma company ) 40mg administered thrice weekly post hemodialysis session
DRUG	Placebo	Film Coated Tablets (Placebo) to be administered thrice weekly post hemodialysis session. same color, taste , size . Same all ingredients except Febuxostat (Active ingredient) .

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2016-08-15
• Last updated: 2018-01-02