Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Endothelial Dysfunction; Endstage Renal Disease

Treatments: Drug: Febuxostat; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02866214

phCL 35

Details and patient eligibility

About

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

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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57 participants in 2 patient groups, including a placebo group

Group I

Experimental group

Description:

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

Treatment:

Drug: Febuxostat

Group II

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo