Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

Phase 2

Completed

• Conditions: Endothelial Dysfunction; Endstage Renal Disease
• Interventions: Drug: Febuxostat; Drug: Placebo

• Registration Number: NCT02866214
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-10
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-28
• Last Update Posted: 2018-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Febuxostat	This Group of Patients will receive Febuxostat Drug along with their Standard Treatment.
Group II	Placebo	This Group of Patients will receive Placebo along with their standard Treatment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.