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

Chronic Kidney Disease Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04983160
• Other study ID #: PI12/01866
• Status: Completed
• Phase: Phase 2
• Start date: February 26, 2014
• Est. completion date: April 29, 2016

Study information

• Verified date: March 2015
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 29, 2016
• Est. primary completion date: April 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Allopurinol
Allopurinol
• Placebo
Placebo

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía de Córdoba	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating endothelial progenitor cells concentration and microparticles derived from endothelial cells	Effect of inhibiting xanthine oxidase with allopurinol in patients with CKD	Data collected after 4 weeks, 8 weeks and 12 weeks.
Secondary	Level of oxidative stress	Evaluated through quantification of oxygen-reactive species	After patient visit (0 weeks, 4, 8 and 12 weeks)
Secondary	Level of micro inflammation	Evaluated through quantification of C-reactive protein, proinflammatory cytokines, CD14+ and CD16+ monocytes	After patient visit (0 weeks, 4, 8 and 12 weeks)
Secondary	Level of endothelial dysfunction	Endothelium-dependant vasodilation in response to ischemia evaluated through changes in capillar flux using Doppler laser PeriFlux system 5000	After patient visit (0 weeks, 4, 8 and 12 weeks)
Secondary	Blood pressure		Each visit (0 weeks, 4 weeks, 8 weeks and 12 weeks) for 24 hours
Secondary	Glomerular filtration ratio	Estimated through MDRD-4 y Cockroft-Gault.	After patient visit (0 weeks, 4 weeks, 8 weeks and 12 weeks)
Secondary	Microalbuminuria / Proteinuria	Evaluated through albumin/creatinin ratio and protein/creatinine ratio	Daily, using first urine of the day as a sample.