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Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

Primary Purpose

Endothelial Dysfunction, Endstage Renal Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Febuxostat
Placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endothelial Dysfunction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Group I

    Group II

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    August 10, 2016
    Last Updated
    December 28, 2017
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02866214
    Brief Title
    Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.
    Official Title
    Evaluation of the Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    October 2016 (Actual)
    Study Completion Date
    October 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    5. Study Description

    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: Primary endpoint: • Reduction in Asymmetrical Dimethylarginine (ADMA) Secondary endpoints: Assessing the change in serum High sensitivity C-reactive protein (hsCRP) Assessing the change in serum Uric acid - The criteria for inclusion: Outpatients on maintenance hemodialysis. Age from 18-70 years old. Serum UA level 7.0 mg/dL or more. Stable clinical condition (no hospitalization in the previous 3 months) The 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endothelial Dysfunction, Endstage Renal Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    57 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I
    Arm Type
    Experimental
    Arm Description
    This Group of Patients will receive Febuxostat Drug along with their Standard Treatment.
    Arm Title
    Group II
    Arm Type
    Placebo Comparator
    Arm Description
    This Group of Patients will receive Placebo along with their standard Treatment.
    Intervention Type
    Drug
    Intervention Name(s)
    Febuxostat
    Other Intervention Name(s)
    Donifoxate
    Intervention Description
    Film Coated Tablets of Donifoxate (Eva Pharma company ) 40mg administered thrice weekly post hemodialysis session
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Film Coated Tablets (Placebo) to be administered thrice weekly post hemodialysis session. same color, taste , size . Same all ingredients except Febuxostat (Active ingredient) .
    Primary Outcome Measure Information:
    Title
    Asymmetric Dimethylarginine physiological marker
    Description
    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.
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    Uric Acid , physiological parameter
    Description
    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.
    Time Frame
    2 months
    Title
    High sensitivity C-reactive protein physiological marker
    Description
    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.
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

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    Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

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