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

NCT ID: NCT04983160

Last Updated: 2021-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-26

Study Completion Date

2016-04-29

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease

Keywords

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chronic kidney disease allopurinol CKD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Allopurinol

Group Type ACTIVE_COMPARATOR

Allopurinol

Intervention Type DRUG

Allopurinol

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Allopurinol

Allopurinol

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rafael Santamaría, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Reina Sofía

Locations

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Hospital Universitario Reina Sofía de Córdoba

Córdoba, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PI12/01866

Identifier Type: -

Identifier Source: org_study_id