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

NCT04983160 | Completed Phase 2

• 1 other identifier: PI12/01866
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

chronic kidney disease; allopurinol; CKD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Level of oxidative stress

  After patient visit (0 weeks, 4, 8 and 12 weeks)

• Level of micro inflammation

  After patient visit (0 weeks, 4, 8 and 12 weeks)

• Level of endothelial dysfunction

  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

  After patient visit (0 weeks, 4 weeks, 8 weeks and 12 weeks)

Study Arms (2)

Allopurinol

ACTIVE COMPARATOR

Drug: Allopurinol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Allopurinol DRUG

Allopurinol

Allopurinol

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Hospital Universitario Reina Sofía de Córdoba

Córdoba, 14002, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rafael Santamaría, MD

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: July 30, 2021
• Study Start: February 26, 2014
• Primary Completion: April 29, 2016
• Study Completion: April 29, 2016
• Last Updated: July 30, 2021

Record last verified: 2015-03

Locations

ES (1)