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

Maimónides Biomedical Research Institute of Córdoba

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease

Treatments: Drug: Allopurinol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04983160

PI12/01866

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

22 participants in 2 patient groups, including a placebo group

Allopurinol

Active Comparator group

Treatment:

Drug: Allopurinol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo