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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Allopurinol
Placebo
Sponsored by
Maimónides Biomedical Research Institute of Córdoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring chronic kidney disease, allopurinol, CKD

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Universitario Reina Sofía de Córdoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Allopurinol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Circulating endothelial progenitor cells concentration and microparticles derived from endothelial cells
Effect of inhibiting xanthine oxidase with allopurinol in patients with CKD

Secondary Outcome Measures

Level of oxidative stress
Evaluated through quantification of oxygen-reactive species
Level of micro inflammation
Evaluated through quantification of C-reactive protein, proinflammatory cytokines, CD14+ and CD16+ monocytes
Level of endothelial dysfunction
Endothelium-dependant vasodilation in response to ischemia evaluated through changes in capillar flux using Doppler laser PeriFlux system 5000
Blood pressure
Glomerular filtration ratio
Estimated through MDRD-4 y Cockroft-Gault.
Microalbuminuria / Proteinuria
Evaluated through albumin/creatinin ratio and protein/creatinine ratio

Full Information

First Posted
March 31, 2015
Last Updated
July 19, 2021
Sponsor
Maimónides Biomedical Research Institute of Córdoba
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1. Study Identification

Unique Protocol Identification Number
NCT04983160
Brief Title
Crossover Clinical Trial, Randomized, Double Blind, Placebo Controlled 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 26, 2014 (Actual)
Primary Completion Date
April 29, 2016 (Actual)
Study Completion Date
April 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimónides Biomedical Research Institute of Córdoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease, allopurinol, CKD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Santamaría, MD
Organizational Affiliation
Hospital Universitario Reina Sofía
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Reina Sofía de Córdoba
City
Córdoba
ZIP/Postal Code
14002
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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