Clinical trial NCT04983160: Crossover Clinical Trial, Randomized, Double Blind, Placebo Controlled Trial
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Disease
Keywords: chronic kidney disease
allopurinol
CKD
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Circulating endothelial progenitor cells concentration and microparticles derived from endothelial cells
timeFrame: Data collected after 4 weeks, 8 weeks and 12 weeks.
Secondary outcomes:
measure: Level of oxidative stress
timeFrame: After patient visit (0 weeks, 4, 8 and 12 weeks)
measure: Level of micro inflammation
timeFrame: After patient visit (0 weeks, 4, 8 and 12 weeks)
measure: Level of endothelial dysfunction
timeFrame: After patient visit (0 weeks, 4, 8 and 12 weeks)
measure: Blood pressure
timeFrame: Each visit (0 weeks, 4 weeks, 8 weeks and 12 weeks) for 24 hours
measure: Glomerular filtration ratio
timeFrame: After patient visit (0 weeks, 4 weeks, 8 weeks and 12 weeks)
measure: Microalbuminuria / Proteinuria
timeFrame: Daily, using first urine of the day as a sample.
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía de Córdoba
Study officials:
affiliation: Hospital Universitario Reina Sofía
name: Rafael Santamaría, MD
role: PRINCIPAL_INVESTIGATOR
References: