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Completed

NCT Number: NCT04983160

Crossover Clinical Trial, Randomized, Double Blind, Placebo Controlled Trial

The purpose of this study is to determine the effect of inhibiting xanthine oxidase with allopurinol in patients with chronic kidney disease in asymptomatic hyperuricemia endothelial injury and vascular repair mechanisms.

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Key information

About this study

The purpose of this study is to determine the effect of inhibiting xanthine oxidase with allopurinol in patients with chronic kidney disease in asymptomatic hyperuricemia endothelial injury and vascular repair mechanisms, evaluating the plasma concentration of angiogenic factors, microparticles of endothelial cells and the cell number circulating endothelial progenitor.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients willing and able to give informed consent for participation in the study
  • Ability to understand study procedures and to comply with it for the duration of the study.
  • Subjects of both sexes, the age range between 18 and 70 years old.
  • Serum uric acid above 7 mg / dl.
  • Estimated glomerular filtration rate by MDRD abbreviated formula less than 60 ml / min / 1.73 m2 and above 15 ml / min / 1.73 m2.
  • Stability of renal function (serum creatinine increase without exceeding 50% in the three months before the start of the study).
  • Clinically stable in terms of no hospitalizations of cardiovascular events in the 3 months before the study began.

Exclusion criteria

  • Drop active in the 60 days prior to study initiation.
  • Use of allopurinol within 60 days preceding baseline
  • Active infections within 30 days prior to baseline.
  • Patients with systemic inflammatory disease
  • Infection with HIV, Hepatitis C and Hepatitis B.
  • History of cancer within 5 years prior to the first dose of study medication
  • Chronic liver disease.
  • Immunosuppressive therapy.
  • Pregnant women, breastfeeding or planning to become pregnant.
  • Allergy or sensitive to allopurinol.
  • Addiction to drugs or alcohol, in the opinion of the investigator, may interfere with compliance with study requirements.
  • Inability or unwillingness of the individual or legal guardian or representative to give written informed consent.

Treatment and study plan

Allopurinol

Drug

Allopurinol

Placebo

Drug

Placebo

Primary outcomes

  1. Circulating endothelial progenitor cells concentration and microparticles derived from endothelial cells

    Time frame: Data collected after 4 weeks, 8 weeks and 12 weeks.

    Effect of inhibiting xanthine oxidase with allopurinol in patients with CKD

Secondary outcomes

  1. Level of oxidative stress

    Time frame: After patient visit (0 weeks, 4, 8 and 12 weeks)

    Evaluated through quantification of oxygen-reactive species

  2. Level of micro inflammation

    Time frame: After patient visit (0 weeks, 4, 8 and 12 weeks)

    Evaluated through quantification of C-reactive protein, proinflammatory cytokines, CD14+ and CD16+ monocytes

  3. Level of endothelial dysfunction

    Time frame: After patient visit (0 weeks, 4, 8 and 12 weeks)

    Endothelium-dependant vasodilation in response to ischemia evaluated through changes in capillar flux using Doppler laser PeriFlux system 5000

  4. Blood pressure

    Time frame: Each visit (0 weeks, 4 weeks, 8 weeks and 12 weeks) for 24 hours

  5. Glomerular filtration ratio

    Time frame: After patient visit (0 weeks, 4 weeks, 8 weeks and 12 weeks)

    Estimated through MDRD-4 y Cockroft-Gault.

  6. Microalbuminuria / Proteinuria

    Time frame: Daily, using first urine of the day as a sample.

    Evaluated through albumin/creatinin ratio and protein/creatinine ratio

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Registry information

Official study title

Crossover Clinical Trial, Randomized, Double Blind, Placebo Controlled Trial. Modulation of Cellular Mediators and Repair Endothelial Damage in Patients With Chronic Renal Disease Through Inhibition of Xanthine Oxidase

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 30, 2021
Registry last updated
Jul 30, 2021

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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