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Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03393663
Acronym
PROGREDIR
Enrollment
454
Registered
2018-01-08
Start date
2012-03-01
Completion date
2013-12-15
Last updated
2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Keywords

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

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.

Interventions

OTHERCKD-related outcomes

the study is observational

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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; * any organ transplantation.

Design outcomes

Primary

MeasureTime frameDescription
Overall Mortality7 yearsMortality of any cause, confirmed by official death certificates obtained through several health offices (PRO-AIM, Fundação SEADE and National Mortality Registry).
Renal replacement therapy7 yearsInitiation 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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026