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

  • End date
    Dec 30, 2022
  • participants needed
  • sponsor
    University of Sao Paulo General Hospital
Updated on 6 October 2021
vitamin d
renal replacement therapy


With 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 initiate dialysis vs. remain 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. These endpoints will be correlated with: geriatric syndromes, markers of mineral and bone metabolism (calcium, phosphorus, Klotho, parathormone,fibroblast growth factor 23, fibroblast growth factor 21, 25(OH) vitamin D and 1,25 vitamin D), cognitive decline, clinical demographic and biochemical data, bone densitometry and echocardiography, and sleep data. Patients will be follow-up at the nephrology outpatient clinic of the Hospital das Clinicas, Universidade de Sao Paulo. The sample size was calculated to be 500 subjects. The summary methodology will include: 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, skull tomography, bone densitometry, ambulatory blood pressure monitoring, actigraphy, polysomnography, Epworth Sleepiness Scale, Pitssburgh questionnaire and segmental electric bioimpedance

Condition Renal Replacement Therapy, Aged, chronic kidney disease, Kidney Failure (Pediatric), Aspects of mortality statistics, Renal Failure, Kidney Failure, Mortality, chronic kidney disease (ckd), Chronic Kidney Diseases
Clinical Study IdentifierNCT04132492
SponsorUniversity of Sao Paulo General Hospital
Last Modified on6 October 2021


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