Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

Endothelial Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866214
• Other study ID #: phCL 35
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 10, 2016
• Last updated: December 28, 2017
• Start date: August 2016
• Est. completion date: October 2016

Study information

• Verified date: December 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Endothelial Dysfunction
• Endstage Renal Disease
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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