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Chronic Kidney DiseasesEPIRCENCT03451929

Kidney Function and Cardiovascular Events: Cohort Study in General Population

An observational study of Chronic Kidney Diseases and Progression, run by María Pilar Gayoso Diz.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Prospective multicenter follow-up study of 10 years. Cohort established between 2005-2007 with stratified random sample of general population older than 20 years (Census 2001), N= 2746 subjects. Read more about this study

Who is it for?
Ages 20 to 90 years
How many people
2,746 participants
Where
No sites listed yet
Study dates
9 Jan 2015to 31 Dec 2018
Phase
Observational
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 20 to 90 years
  • All sexes
  • Adult, Older adult

Study population: A random sample, stratified by age and sex, of the over 20 population, representative of the general adult Spanish population. The sample population was the 2001 Census (National Statistical Institute of Spain, INE). Sample size: 2746 subjects studied in Phase I of the EPIRCE study are included. This sample size allows for a 1.17% accuracy rate for the estimate of a proportion (prevalence) in a maximum dispersion variable (p = q = 0.5) with a 95% confidence interval.

Who may be able to join

  • Subjects studied in Phase I of the EPIRCE study. Give their informed consent to participate in this phase of EPIRCE 2 study.

Who cannot join

  • Exclusion criteria: subjects that cannot be located or who refuse to give their consent to participate in this monitoring phase will be excluded.

About this study

Official title: Kidney Function and Markers of Inflamation in Relation to Mortality, Cardiovascular Events and Kidney Function Impaired: Cohort Study in General Adult Population

Prospective multicenter follow-up study of 10 years. Cohort established between 2005-2007 with stratified random sample of general population older than 20 years (Census 2001), N= 2746 subjects.

Read the detailed description

The aim of this study is to analyse the evolution of kidney function (KF) in the general Spanish population and its impact in terms of quality of life, survival and prognosis for relevant clinical events: mortality, major vascular events and end stage renal disease (ESRD), over a period of 10 years. This is in line with the research priorities highlighted by Kidney Disease: Improving Global Outcomes (KDIGO) 2012.

The study is a prospective multi-centre 10 year follow-up study. Cohort established in Phase I of the EPIRCE study conducted in 2005-2007; stratified random sample of the general population over age 20 (2001 Census), with 2746 subjects studied with complete baseline characterization: socio-demographic variables, lifestyle factors, vascular risk, morbidity, and RF. Cox proportional hazard additive predictors will be used to study the predictive value of renal function models. All models will be adjusted for socio-demographic factors and lifestyle. IDI and NRI will be used to determine whether the addition of KF improves the predictive ability of the existing scores. Decision curve analysis will be used to indicate different KF cut-off points take cost and benefit into account in the decision to treat or not treat.

This project addresses the predictive capacity of glomerular filtration and albuminuria on mortality and vascular events after a 10-year follow-up in the general population, with an analysis of potential improvement in predicting vascular mortality and/or major vascular events by incorporating renal function into existing scales. It also establishes associated serum DNA samples to a well phenotyped cohort for subsequent studies of gene expression and inflammatory markers on CKD. These results will therefore provide insight into the natural evolution of CKD and associated vascular risk.

Keywords
primary healthcare, cohort
Medical subject headings
Renal Insufficiency, Chronic, Disease Progression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impaired renal function

    50% reduction in the glomerular filtration rate with respect to the baseline

    Measured: 2005-2018, up to 10 years

  2. mortality

    mortality due to cardiovascular problems or any others

    Measured: 2005-2018, up to 10 years

  3. ACS

    acute coronary syndrome

    Measured: 2005-2018, up to 10 years

  4. stroke

    ischemic, due to lack of blood flow, and hemorrhagic, due to bleeding.

    Measured: 2005-2018, up to 10 years

Secondary outcomes (2)

  1. health related quality of life

    SF-12

    Measured: 2014-2018

  2. depression or anxiety

    Hospital Anxiety Depression Scale (HADS)

    Measured: 2014-2018

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2018
  2. Study start9 Jan 2015
  3. Primary completion30 Jun 2018 (estimated)
  4. Study completion31 Dec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,746 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03451929
Sponsor's protocol ID
EPIRCE2
Other IDs
PI13/02031
Acronym
EPIRCE
Status last verified
Feb 2018
First submitted
26 Feb 2018
Last updated
2 Mar 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Diseases and Progression, run by María Pilar Gayoso Diz.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

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?

Impaired renal function (time frame: 2005-2018, up to 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03451929.

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 2 Mar 2018; AzTrials last refreshed its copy on 28 Oct 2026.

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