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

Completed

• Conditions: Elderly; Renal Replacement Therapy; Chronic Kidney Diseases; Mortality

• Registration Number: NCT04132492
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined events mortality-dialysis	through study completion, an average of 2 years	dialysis or death

Trial Locations

Locations (2)

Hospital das Clinicas; 🇧🇷 Sao Paulo, SP, Brazil

Unersidade de São Paulo; 🇧🇷 São Paulo, Brazil