Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk (PROGREDIR)
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|ClinicalTrials.gov Identifier: NCT03393663|
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Chronic kidney disease has become an important Public Health issue in most developed and developing countries, with increasing incidence and prevalence rates. The cost associated with chronic kidney disease patients is very high, derived from renal replacement therapy and the cost associated with the high cardiovascular risk of this population. Primary and secondary preventive measures are imperative. In this sense, the comprehension of mechanisms and biomarkers associated with CKD progression and mortality risk in this population is an important area of research. Cohort studies are important tools for testing risk factors and biomarkers. Currently, CKD cohorts, particularly of those not on dialysis, are few and restricted to North America and Europe.
The present study established a cohort of 454 CKD participants (not on dialysis) in Sao Paulo, Brazil, who will be followed for 7-10 years. Baseline data collection was wide, including medical history, diet (food frequency questionnaire), calcium score, echocardiography, pulse wave velocity, cardiac frequency variability, carotid intimal media thickness, retinography, and an extensive biobank. Follow-up is ongoing and made through annual telephone interviews including questions on death, hospitalizations, and need of renal replacement therapy (RRT). Vital status is investigated periodically by a hot-pursuit strategy.
|Condition or disease||Intervention/treatment|
|Chronic Kidney Diseases||Other: CKD-related outcomes|
|Study Type :||Observational|
|Actual Enrollment :||454 participants|
|Official Title:||Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk. A Cohort Study in a Brazilian Population|
|Actual Study Start Date :||March 1, 2012|
|Actual Primary Completion Date :||December 15, 2013|
|Actual Study Completion Date :||December 15, 2013|
- Other: CKD-related outcomes
the study is observational
- Overall Mortality [ Time Frame: 7 years ]Mortality of any cause, confirmed by official death certificates obtained through several health offices (PRO-AIM, Fundação SEADE and National Mortality Registry).
- Renal replacement therapy [ Time Frame: 7 years ]
Initiation of any modality of renal replacement therapy, even if not permanently.
Besides participant information, RRT will be ascertained through the city and state´s Registries (Sao Paulo State Registry of Dialysis and Transplantation, Sao Paulo City Registry of Dialysis and Transplantation).
Biospecimen Retention: Samples With DNA
Urine (midstream sample and 24h collection) and blood (fasting serum, fasting plasma, post OGGT serum, post OGGT plasma) aliquots were prepared and stored at -180 °C in nitrogen.
DNA extraction was performed stored at -80°C.