Endothelial Dysfunction, Endstage Renal Disease
Conditions
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.
Interventions
DRUGFebuxostat
Film Coated Tablets of Donifoxate (Eva Pharma company ) 40mg administered thrice weekly post hemodialysis session
DRUGPlacebo
Film Coated Tablets (Placebo) to be administered thrice weekly post hemodialysis session. same color, taste , size . Same all ingredients except Febuxostat (Active ingredient) .
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asymmetric Dimethylarginine physiological marker | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uric Acid , physiological parameter | 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 | 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. |
Outcome results
None listed