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.

Conditions: Patients with chronic kidney disease and asymptomatic hyperuricemia on the balance of mechanisms of vascular injury and repair.
MedDRA version: 16.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-001640-56-ES

Lead Sponsor: Fundación Para la Investigación Biomédica de Córdoba

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Patient 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 than 7 mg / dl.
- Estimated glomerular filtration rate by MDRD abbreviated formula less than 60 ml / min/1.73m2 and above 15 ml/min/1.73m2.
- 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 or cardiovascular events in the 3 months before the study began.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 sensitivity 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.