Chronic Kidney Disease: Determinants of Progression and Cardiovascular Risk

Chronic Kidney Diseases Clinical Trial

— PROGREDIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393663
• Other study ID #: 2011/17341-0
• Status: Completed
• Phase: N/A
• First received: December 20, 2017
• Last updated: January 5, 2018
• Start date: March 1, 2012
• Est. completion date: December 15, 2013

Study information

• Verified date: January 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 454
• Est. completion date: December 15, 2013
• Est. primary completion date: December 15, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• CKD-related outcomes
the study is observational

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

References & Publications (3)

Domingos MA, Moreira SR, Gomez L, Goulart A, Lotufo PA, Benseñor 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. — View Citation

Domingos MAM, Goulart AC, Lotufo PA, Benseñor 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: 10.1590/1516-3180.20 — View Citation

Domingos MAM, Queiroz M, Lotufo PA, Benseñor 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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