Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

NCT02866214 | Completed Phase 2

• 1 other identifier: phCL 35
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Endothelial Dysfunction; Endstage Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Uric Acid , physiological parameter

  2 months

• High sensitivity C-reactive protein physiological marker

  2 months

Study Arms (2)

Group I

EXPERIMENTAL

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

Drug: Febuxostat

Group II

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Febuxostat DRUG

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

Also known as: Donifoxate

Group I

Placebo DRUG

Film Coated Tablets (Placebo) to be administered thrice weekly post hemodialysis session. same color, taste , size . Same all ingredients except Febuxostat (Active ingredient) .

Group II

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Interventions

Febuxostat

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administrator at clinical pharmacy department .

Study Record Dates

• First Submitted: August 10, 2016
• First Posted: August 15, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 2, 2018

Record last verified: 2017-12