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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04983160
Other study ID # PI12/01866
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 26, 2014
Est. completion date April 29, 2016

Study information

Verified date March 2015
Source Maimónides Biomedical Research Institute of Córdoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date April 29, 2016
Est. primary completion date April 29, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Intervention

Drug:
Allopurinol
Allopurinol
Placebo
Placebo

Locations

Country Name City State
Spain Hospital Universitario Reina Sofía de Córdoba Córdoba

Sponsors (1)

Lead Sponsor Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Circulating endothelial progenitor cells concentration and microparticles derived from endothelial cells Effect of inhibiting xanthine oxidase with allopurinol in patients with CKD Data collected after 4 weeks, 8 weeks and 12 weeks.
Secondary Level of oxidative stress Evaluated through quantification of oxygen-reactive species After patient visit (0 weeks, 4, 8 and 12 weeks)
Secondary Level of micro inflammation Evaluated through quantification of C-reactive protein, proinflammatory cytokines, CD14+ and CD16+ monocytes After patient visit (0 weeks, 4, 8 and 12 weeks)
Secondary Level of endothelial dysfunction Endothelium-dependant vasodilation in response to ischemia evaluated through changes in capillar flux using Doppler laser PeriFlux system 5000 After patient visit (0 weeks, 4, 8 and 12 weeks)
Secondary Blood pressure Each visit (0 weeks, 4 weeks, 8 weeks and 12 weeks) for 24 hours
Secondary Glomerular filtration ratio Estimated through MDRD-4 y Cockroft-Gault. After patient visit (0 weeks, 4 weeks, 8 weeks and 12 weeks)
Secondary Microalbuminuria / Proteinuria Evaluated through albumin/creatinin ratio and protein/creatinine ratio Daily, using first urine of the day as a sample.
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