Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk

Completed

• Conditions: Chronic Kidney Diseases

• Registration Number: NCT03393663
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2012-03-01
• Primary Completion: 2013-12-15
• Study Completion: 2013-12-15
• Study First Submitted: 2017-12-20
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-05
• Last Update Submitted: 2018-01-05
• Study First Posted: 2018-01-08
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 454

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.

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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;
• any organ transplantation.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Renal replacement therapy	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	7 years	Mortality of any cause, confirmed by official death certificates obtained through several health offices (PRO-AIM, Fundação SEADE and National Mortality Registry).