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Completed

NCT Number: NCT02866214

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.

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Key information

Conditions

Endothelial Dysfunction Endstage Renal Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Febuxostat

Drug

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

Other names: Donifoxate

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) .

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 15, 2016
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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