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Clinical Trials/NCT03393663
NCT03393663
Completed
Not Applicable

Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk. A Cohort Study in a Brazilian Population

University of Sao Paulo0 sites454 target enrollmentMarch 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Diseases
Sponsor
University of Sao Paulo
Enrollment
454
Primary Endpoint
Renal replacement therapy
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2012
End Date
December 15, 2013
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Silvia Maria de Oliveira Titan

Principal Investigator, MD-PhD

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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;

Outcomes

Primary Outcomes

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).

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).

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