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.

Fundación Para la Investigación Biomédica de Córdoba0 个研究点开始时间: 2013年9月16日最近更新: 2014年2月10日

适应症

试验速览

暂无简介。

•- 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

•- 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.

发起方

Fundación Para la Investigación Biomédica de Córdoba