Skip to main content
OpenTrials
Completed

NCT Number: NCT04132492

AGNES - Aging Nephropathy Study, a Prospective Observational Cohort of Chronic Kidney Disease in Elderly Patients

With the aging population, a high prevalence of obesity, systemic arterial hypertension and diabetes mellitus, we are facing an increased incidence of elderly patients with chronic kidney disease (CKD) initiating renal replacement therapy. The correct diagnosis of CKD, the prognosis of the elderly patient with CKD, mainly comparing initiated dialysis vs. remaining in conservative treatment, the nutritional prognostic markers (sarcopenia), cardiovascular, mineral and bone metabolism, geriatric syndromes and sleep disorders are still debatable. Elderly patients are usually excluded from clinical trials and the scientific evidence is either scarce or based on retrospective data. Thus, the present study is a prospective cohort to evaluate the long-term evolution of patients ≥ 70 years with stage 4 or 5 CKD. The main outcomes are mortality and dialysis as a combined event. These endpoints will be correlated with independent parameters: Klotho, FGF23, nutrition and sleep quality. Confounders variables are cognition, depression, demographic, clinical and laboratory parameters, and daytime somnolence. Patients will be followed at the nephrology outpatient clinic of the Hospital das Clinicas, Universidade de Sao Paulo. The sample size was calculated to be 200 subjects. The summary methodology will include a broad geriatric assessment, cognition test, fragility, Charlson comorbidity scores, biochemical measurements of urea, creatinine, alkaline phosphatase, parathyroid hormone, calcium, phosphorus, vitamin D, vitamin B12, folic acid, thyroid hormones, hepatitis virus, serum albumin, albumin/creatinine ratio, protein/creatinine ratio, 24-h urinary protein, Epworth Sleepiness Scale, Pittsburgh questionnaire, segmental electric bioimpedance, and nutritional evaluation by 24h dietary interview.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Main outcome: combined event mortality-dialysis

Independent variables: nutrition status, sleep quality, Klotho and FGF-23 Confounders: clinical and demographic variables, Charlson comorbidity index, Laboratory parameters, depression, functionality, cognition.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Clinical diagnosis of Chronic Kidney Disease stage 4 or 5
  • Minimal age of 70 years
  • Must be able to understand and sign the consent form

Exclusion criteria

  • Patients who did not accept and sign the consent form
  • Patients with cancer and life expectance lower than 6 months
  • Moderate to advanced dementia

Treatment and study plan

No intervention

Other

there is no intervention

Primary outcomes

  1. Combined events mortality-dialysis

    Time frame: through study completion, an average of 2 years

    dialysis or death

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Acronym: AGNES

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 18, 2019
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.