Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk

NCT03393663 | Completed

• 1 other identifier: 2011/17341-0
• Study Type: observational
• Target: 454
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Kidney Diseases

Keywords

chronic kidney disease; cardiovascular disease; mortality; end stage renal disease

Outcome Measures

Primary Outcomes (2)

• Overall Mortality

  Mortality of any cause, confirmed by official death certificates obtained through several health offices (PRO-AIM, Fundação SEADE and National Mortality Registry).

  7 years

• Renal replacement therapy

  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).

  7 years

Interventions

CKD-related outcomes OTHER

the study is observational

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending the outpatient service of Hospital das Clínicas, São Paulo, a public university facility providing quaternary-level care for patients with chronic diseases, were invited to participate in this study. Initially, from the outpatient records, all patients aged ≥ 30 years and at least two measurements of creatinine (with a minimum interval of 3 months) ≥ 1.6 mg/dl for men and ≥ 1.4 mg/ dl for women were considered potential candidates. Patients attending oncology, psychiatry, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), viral hepatitis and glomerulonephritis services were excluded. The remaining candidates were then contacted by phone and were invited to participate if they did not meet any exclusion criteria.

You may qualify if:

• Patients attending the outpatient service of Hospital das Clínicas, São Paulo, Brazil.
• ≥ 30 years.
• at least two measurements of creatinine (with a minimum interval of 3 months) ≥ 1.6 mg/dl for men and ≥ 1.4 mg/ dl for women.

You may not qualify if:

• Patients attending oncology, psychiatry, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), viral hepatitis and glomerulonephritis services were excluded.
• hospitalization within the last six months;
• acute myocardial infarction within the last six months;
• autoimmune diseases;
• current pregnancy;
• psychiatric diseases;
• ongoing chemotherapy or immunosuppressive therapy;
• current renal replacement therapy;
• HIV/AIDS infection;
• hepatitis B or C;
• any organ transplantation.

Sponsors & Collaborators

• University of Sao Paulo: lead

Related Publications (3)

• Domingos MAM, Queiroz M, Lotufo PA, Bensenor IJ, Titan SMO. Serum RBP4 and CKD: Association with insulin resistance and lipids. J Diabetes Complications. 2017 Jul;31(7):1132-1138. doi: 10.1016/j.jdiacomp.2017.04.013. Epub 2017 Apr 18.

  PMID: 28473187 BACKGROUND

• Domingos MA, Moreira SR, Gomez L, Goulart A, Lotufo PA, Bensenor I, Titan S. Urinary Retinol-Binding Protein: Relationship to Renal Function and Cardiovascular Risk Factors in Chronic Kidney Disease. PLoS One. 2016 Sep 21;11(9):e0162782. doi: 10.1371/journal.pone.0162782. eCollection 2016.

  PMID: 27655369 BACKGROUND

• Domingos MAM, Goulart AC, Lotufo PA, Bensenor IJM, Titan SMO. Chronic kidney disease - determinants of progression and cardiovascular risk. PROGREDIR cohort study: design and methods. Sao Paulo Med J. 2017 Mar-Apr;135(2):133-139. doi: 10.1590/1516-3180.2016.0272261116. Epub 2017 Apr 20.

  PMID: 28443950 RESULT

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.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases; Kidney Failure, Chronic

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD-PhD

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 8, 2018
• Study Start: March 1, 2012
• Primary Completion: December 15, 2013
• Study Completion: December 15, 2013
• Last Updated: January 8, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share