Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

NCT ID: NCT02866214

Last Updated: 2018-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2016-10-31

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.

Conditions

Endothelial Dysfunction; Endstage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group I

This Group of Patients will receive Febuxostat Drug along with their Standard Treatment.

Group Type: EXPERIMENTAL

Febuxostat

Intervention Type: DRUG

Film Coated Tablets of Donifoxate (Eva Pharma company ) 40mg administered thrice weekly post hemodialysis session

Group II

This Group of Patients will receive Placebo along with their standard Treatment.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Film Coated Tablets (Placebo) to be administered thrice weekly post hemodialysis session.

same color, taste , size . Same all ingredients except Febuxostat (Active ingredient) .

Interventions

Febuxostat

Film Coated Tablets of Donifoxate (Eva Pharma company ) 40mg administered thrice weekly post hemodialysis session

Intervention Type: 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) .

Intervention Type: DRUG

Other Intervention Names

Donifoxate

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mona AlShahawey AlSayed Ghazy

Administrator at clinical pharmacy department .

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

phCL 35

Identifier Type: -

Identifier Source: org_study_id