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Trial record 21 of 7870 for:    "Kidney Diseases"

Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk (PROGREDIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03393663
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Silvia Maria de Oliveira Titan, 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.


Condition or disease Intervention/treatment
Chronic Kidney Diseases Other: CKD-related outcomes

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Study Type : Observational
Actual Enrollment : 454 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases


Intervention Details:
  • Other: CKD-related outcomes
    the study is observational


Primary Outcome Measures :
  1. 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).

  2. 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.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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;
  • any organ transplantation.

Publications of Results:
Other Publications:
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Responsible Party: Silvia Maria de Oliveira Titan, Principal Investigator, MD-PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03393663     History of Changes
Other Study ID Numbers: 2011/17341-0
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Silvia Maria de Oliveira Titan, University of Sao Paulo:
chronic kidney disease
cardiovascular disease
mortality
end stage renal disease

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency