An observational study in Chronic Kidney Diseases, Progression and Cardiovascular Morbidity, sponsored by María Pilar Gayoso Diz. Status unknown. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-03-02.
Sponsored by María Pilar Gayoso Diz · Observational
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.
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.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 2,746 is above the median of 213 across 834 observational studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →This is the only study on the registry with María Pilar Gayoso Diz as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Impaired renal function
50% reduction in the glomerular filtration rate with respect to the baseline
Time frame: 2005-2018, up to 10 years
mortality
mortality due to cardiovascular problems or any others
Time frame: 2005-2018, up to 10 years
ACS
acute coronary syndrome
Time frame: 2005-2018, up to 10 years
stroke
ischemic, due to lack of blood flow, and hemorrhagic, due to bleeding.
Time frame: 2005-2018, up to 10 years
health related quality of life
SF-12
Time frame: 2014-2018
depression or anxiety
Hospital Anxiety Depression Scale (HADS)
Time frame: 2014-2018
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2015 (actual). Primary completion is estimated for Jun 2018, 41 months after the start.
Of 274 non-industry observational studies under Renal Insufficiency, Chronic, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 192. This study's planned 41 months is below that.
Counting every sponsor, half of 325 studies reached it within 45 months; a quarter within 22 and three quarters within 191.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →