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Validation study of the AGE-Reader device (Trade Mark) in the Brazilian population with or without kidney diseases

Validation study of the AGE-Reader (Trade Mark) in a sample of the Brazilian population with and without chronic kidney disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8sk5j9
Enrollment
Unknown
Registered
2018-08-01
Start date
2018-08-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Atherosclerotic cardiovascular disease

Interventions

600 volunteers will be included in the research, divided into two distinct groups, control group (n: 300) and group with chronic kidney disease (n: 300). All patients will be submitted to quantificati
Device

Sponsors

Serviço de Nefrologia do Departamento de Clínica Médica da Faculdade de Ciências Médicas (FCM) da Universidade Estadual de Campinas (UNICAMP),
Lead Sponsor
Faculdade de Ciências Médicas da Universidade Estadual de Campinas
Collaborator

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Control group: Will include 300 individuals with age greater than or equal to 18 years; with Fitzpatrick skin phototype I to IV; no history of Diabetes Mellitus and Chronic Renal Disease or smoking. Chronic Kidney Disease Group (CKD): 300 patients with CKD according to the criteria of Kidney International Disease Improvement Global Outcome (KDIGO) and treated at the HC-FCM-UNICAMP Nephrology Service; 75 of them in stage 3B of CKD, 75 in stage 4 or 5 non-dialytic of CKD, 75 on hemodialysis, and 75 on peritoneal dialysis; with age greater than or equal to 18 years. Patients with DM or smokers will not be excluded.

Exclusion criteria

Exclusion criteria: Control Group: Individuals aged younger than 18 years; with Fitzpatrick skin type VI to VI; with a history of Diabetes Mellitus and smoking; and individuals who do not agree with the terms set forth in the Free and Informed Consent Term will be excluded. Chronic Kidney Disease Group: Individuals aged younger than 18 years; with a Fitzpatrick skin V to VI phototype; individuals who do not agree with the terms set forth in the Free and Informed Consent Term will be excluded.

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is to validate the use of the AGEReader ™ device as a noninvasive tool for the indirect quantification of AGEs through skin AF in a sample of the Brazilian population of subjects without and with CKD (stages 3B to 5, and in patients in dialysis (hemodialysis and peritoneal dialysis)

Secondary

MeasureTime frame
To evaluate the distribution of AGEs through skin AF in the Brazilian population according to age, gender and skin phototype;To compare the amount of AGEs in healthy individuals with chronic kidney disease, through skin AF

Countries

Brazil

Contacts

Public ContactRafael Sano

Faculdade de Ciências Médicas da Universidade Estadual de Campinas

rysano@gmail.com+55-015-991435094

Outcome results

None listed

Source: REBEC (via WHO ICTRP)