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Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT02866214
Collaborator
(none)
57
Enrollment
2
Arms
2
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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)

  1. 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:
  1. ADMA serum level. B. Change in serum hsCRP. C. Change in serum Uric acid level.

Study Design

Study Type:
Interventional
Actual Enrollment :
57 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.
Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Oct 1, 2016

Arms and Interventions

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) .

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mona AlShahawey AlSayed Ghazy, Administrator at clinical pharmacy department ., Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT02866214
    Other Study ID Numbers:
    • phCL 35
    First Posted:
    Aug 15, 2016
    Last Update Posted:
    Jan 2, 2018
    Last Verified:
    Dec 1, 2017
    Additional relevant MeSH terms:
    Kidney Failure, Chronic
    Febuxostat

    Study Results

    No Results Posted as of Jan 2, 2018