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Effect of Febuxostat on Endothelial Dysfunction in Hemodialysis Patients.

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ClinicalTrials.gov Identifier: NCT02866214
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
Mona AlShahawey AlSayed Ghazy, 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.

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Endstage Renal Disease Drug: Febuxostat Drug: Placebo 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)

  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.


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Study Type : Interventional  (Clinical Trial)
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 : August 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Febuxostat

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 Name: 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) .





Primary Outcome Measures :
  1. Asymmetric Dimethylarginine physiological marker [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Mona AlShahawey AlSayed Ghazy, Administrator at clinical pharmacy department ., Ain Shams University
ClinicalTrials.gov Identifier: NCT02866214     History of Changes
Other Study ID Numbers: phCL 35
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017

Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Febuxostat
Gout Suppressants
Antirheumatic Agents