Chronic Kidney DiseasePhase 2NCT04983160
Crossover Clinical Trial, Randomized, Double Blind, Placebo Controlled Trial
A Phase 2 study testing Allopurinol in people with Chronic Kidney Disease, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Allopurinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 26 Feb 2014to 29 Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Allopurinol, Placebo
- Keywords
- chronic kidney disease, allopurinol, CKD
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Allopurinol
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | Active comparator | Not described Receives: Drug: Allopurinol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating endothelial progenitor cells concentration and microparticles derived from endothelial cells
Effect of inhibiting xanthine oxidase with allopurinol in patients with CKD
Measured: Data collected after 4 weeks, 8 weeks and 12 weeks.
Secondary outcomes (6)
Level of oxidative stress
Evaluated through quantification of oxygen-reactive species
Measured: 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
Measured: 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
Measured: After patient visit (0 weeks, 4, 8 and 12 weeks)
Blood pressure
Measured: Each visit (0 weeks, 4 weeks, 8 weeks and 12 weeks) for 24 hours
Glomerular filtration ratio
Estimated through MDRD-4 y Cockroft-Gault.
Measured: After patient visit (0 weeks, 4 weeks, 8 weeks and 12 weeks)
Microalbuminuria / Proteinuria
Evaluated through albumin/creatinin ratio and protein/creatinine ratio
Measured: Daily, using first urine of the day as a sample.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start26 Feb 2014
- Primary completion29 Apr 2016
- Study completion29 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Santamaría, MD, Principal investigator, Hospital General Universitario Reina Sofía de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983160
- Sponsor's protocol ID
- PI12/01866
- Status last verified
- Mar 2015
- First submitted
- 31 Mar 2015
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04983160
- Acronym / sponsor ID
- PI12/01866
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, allopurinol, CKD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 26 Feb 2014 (actual)
- Primary completion
- 29 Apr 2016 (actual)
- Study completion
- 29 Apr 2016 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Active comparator | Drug: Allopurinol |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllopurinolAllopurinol | Drug | Allopurinol |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Circulating endothelial progenitor cells concentration and microparticles derived from endothelial cells
Time frame: Data collected after 4 weeks, 8 weeks and 12 weeks.
Effect of inhibiting xanthine oxidase with allopurinol in patients with CKD
6 secondary outcomes
Level of oxidative stress
Time frame: After patient visit (0 weeks, 4, 8 and 12 weeks)
Level of micro inflammation
Time frame: After patient visit (0 weeks, 4, 8 and 12 weeks)
Level of endothelial dysfunction
Time frame: After patient visit (0 weeks, 4, 8 and 12 weeks)
Blood pressure
Time frame: Each visit (0 weeks, 4 weeks, 8 weeks and 12 weeks) for 24 hours
Glomerular filtration ratio
Time frame: After patient visit (0 weeks, 4 weeks, 8 weeks and 12 weeks)
Microalbuminuria / Proteinuria
Time frame: Daily, using first urine of the day as a sample.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Santamaría, MD principal investigator
Hospital General Universitario Reina Sofía de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allopurinol in people with Chronic Kidney Disease, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating endothelial progenitor cells concentration and microparticles derived from endothelial cells (time frame: Data collected after 4 weeks, 8 weeks and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.