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Pre-Exposure Prophylaxis (PrEP) effects on kidney

Renal Function assessment among people who uses Pre-Exposure Prophylaxis (PrEP) - PEEK: Prep EffEcts on Kidney

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-87ckkh
Enrollment
Unknown
Registered
2019-07-12
Start date
2018-10-04
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

Tenofovir

Interventions

It is a prospective cohort study in which individuals will be observed through their time of using PrEP. Subjects will not be observed separately or receive any intervention. A hundred (100)individual
Other

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Lead Sponsor
Universidade Federal de São Paulo
Collaborator

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 18 years old or older; normal renal function by the beginning of the study protocol with estimated glomerular filtration ratio greater or equal to 90 mL/min; systolic blood pressure less or equal to 130 mmHg and diastolic blood pressure less or equal to 90 mmHg; no diagnosis of diabetes mellitus

Exclusion criteria

Exclusion criteria: to decide withdraw from this study; to present adverse renal events not related to PrEP use; diabetes mellitus diagnosis during the observational procotocol

Design outcomes

Primary

MeasureTime frame
Appearance of laboratorial abnormalities within a year in blood analysis and urinalysis with one of the following criteria at least: normoglycemic glycosuria > 0,3 g/L, RBP (retinol=binding protein) > 40 mg/mL, proteinuria > 0,05 g/L, hematuria > 10 erythrocytes/hpf with dimorphism and albuminuria > 26 mg/g of creatinine.

Secondary

MeasureTime frame
Renal failure within a year in blood analysis with a rise by 1,5-1,9 times the baseline (before PrEP) creatinine.

Countries

Brazil

Contacts

Public ContactDanilo Fernandes

Universidade Federal de São Paulo

defernandes@unifesp.br+55-11-999832212

Outcome results

None listed

Source: REBEC (via WHO ICTRP)