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

NCT04132492 | Completed DMC

• 1 other identifier: AGNES
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Kidney Diseases; Elderly; Mortality; Renal Replacement Therapy

Outcome Measures

Primary Outcomes (1)

• Combined events mortality-dialysis

  dialysis or death

  through study completion, an average of 2 years

Interventions

no intervention OTHER

there is no intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Outpatients with CKD that have been followed in the nephrology service - Nephrogeriatric ambulatory

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (2)

Hospital das Clinicas

São Paulo, São Paulo, 05403-000, Brazil

Location

Unersidade de São Paulo

São Paulo, São Paulo, 05410002, Brazil

Location

Related Publications (1)

• Coelho VA, Santos GG, Avesani CM, Bezerra CIL, Silva LCA, Lauar JC, Lindholm B, Stenvinkel P, Jacob-Filho W, Noronha IL, Zatz R, Moyses RMA, Elias RM. Design and methodology of the Aging Nephropathy Study (AGNES): a prospective cohort study of elderly patients with chronic kidney disease. BMC Nephrol. 2020 Nov 7;21(1):461. doi: 10.1186/s12882-020-02116-w.

  PMID: 33160321 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and plasma

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rosilene Elias, MD, Ph.D.

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 18, 2019
• Study Start: September 1, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

BR (2)