Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

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

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

Study Overview

• Status: Completed
• Conditions: Endothelial Dysfunction; Endstage Renal Disease
• Intervention / Treatment: Drug: Febuxostat; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group I; This Group of Patients will receive Febuxostat Drug along with their Standard Treatment.	Drug: Febuxostat; Film Coated Tablets of Donifoxate (Eva Pharma company ) 40mg administered thrice weekly post hemodialysis session; Other Names: Donifoxate
PLACEBO_COMPARATOR: Group II; This Group of Patients will receive Placebo along with their standard Treatment.	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) .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: August 10, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (ESTIMATE): August 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 2, 2018
• Last Update Submitted That Met QC Criteria: December 28, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Antirheumatic Agents; Gout Suppressants; Febuxostat
• Other Study ID Numbers: phCL 35