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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04132492
Acronym
AGNES
Enrollment
151
Registered
2019-10-18
Start date
2019-09-01
Completion date
2024-12-30
Last updated
2025-04-03

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

Conditions

Chronic Kidney Diseases, Elderly, Mortality, Renal Replacement Therapy

Brief summary

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.

Detailed description

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.

Interventions

OTHERno intervention

there is no intervention

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Combined events mortality-dialysisthrough study completion, an average of 2 yearsdialysis or death

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026