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Clinical Trial Details

Trial ID: L0136
Source ID: NCT04983160
Associated Drug: Allopurinol
Title: Crossover Clinical Trial, Randomized, Double Blind, Placebo Controlled Trial
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: Allopurinol|DRUG: Placebo
Outcome Measures: 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)|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)|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)|Blood pressure, Each visit (0 weeks, 4 weeks, 8 weeks and 12 weeks) for 24 hours|Glomerular filtration ratio, Estimated through MDRD-4 y Cockroft-Gault., After patient visit (0 weeks, 4 weeks, 8 weeks and 12 weeks)|Microalbuminuria / Proteinuria, Evaluated through albumin/creatinin ratio and protein/creatinine ratio, Daily, using first urine of the day as a sample.
Sponsor/Collaborators: Sponsor: Maimónides Biomedical Research Institute of Córdoba
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 22
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-02-26
Completion Date: 2016-04-29
Results First Posted:
Last Update Posted: 2021-07-30
Locations: Hospital Universitario Reina Sofía de Córdoba, Córdoba, 14002, Spain
URL: https://clinicaltrials.gov/show/NCT04983160