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

Sponsor

Maimónides Biomedical Research Institute of Córdoba (Other)

Overall Status

Completed

CT.gov ID

NCT04983160

Collaborator

(none)

Enrollment

Location

Arms

26.1

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease	Drug: Allopurinol Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 26, 2014

Actual Primary Completion Date :

Apr 29, 2016

Actual Study Completion Date :

Apr 29, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Allopurinol	Drug: Allopurinol Allopurinol
Placebo Comparator: Placebo	Drug: Placebo Placebo

Arm

Intervention/Treatment

Active Comparator: Allopurinol

Drug: Allopurinol

Allopurinol

Placebo Comparator: Placebo

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Circulating endothelial progenitor cells concentration and microparticles derived from endothelial cells [Data collected after 4 weeks, 8 weeks and 12 weeks.]
Effect of inhibiting xanthine oxidase with allopurinol in patients with CKD

Secondary Outcome Measures

Level of oxidative stress [After patient visit (0 weeks, 4, 8 and 12 weeks)]
Evaluated through quantification of oxygen-reactive species
Level of micro inflammation [After patient visit (0 weeks, 4, 8 and 12 weeks)]
Evaluated through quantification of C-reactive protein, proinflammatory cytokines, CD14+ and CD16+ monocytes
Level of endothelial dysfunction [After patient visit (0 weeks, 4, 8 and 12 weeks)]
Endothelium-dependant vasodilation in response to ischemia evaluated through changes in capillar flux using Doppler laser PeriFlux system 5000
Blood pressure [Each visit (0 weeks, 4 weeks, 8 weeks and 12 weeks) for 24 hours]
Glomerular filtration ratio [After patient visit (0 weeks, 4 weeks, 8 weeks and 12 weeks)]
Estimated through MDRD-4 y Cockroft-Gault.
Microalbuminuria / Proteinuria [Daily, using first urine of the day as a sample.]
Evaluated through albumin/creatinin ratio and protein/creatinine ratio

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.