Design and methodology of the Aging Nephropathy Study (AGNES): a prospective cohort study of elderly patients with chronic kidney disease

Renal replacement therapy (RRT) is usually indicated for patients with chronic kidney disease (CKD) with glomerular filtration rate below 10 ml/ml/min/1.73m . However, the need for RRT and timing of dialysis initiation are debatable for patients aged 70 years or older. We here describe the study des...

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Bibliographic Details
Published in:	BMC nephrology Vol. 21; no. 1; p. 461
Main Authors:	Coelho, Venceslau A, Santos, Giovani Gn, Avesani, Carla M, Bezerra, Cicero Italo L, Silva, Luana Cristina A, Lauar, Julia C, Lindholm, Bengt, Stenvinkel, Peter, Jacob-Filho, Wilson, Noronha, Irene L, Zatz, Roberto, Moysés, Rosa M A, Elias, Rosilene M
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 07-11-2020 BioMed Central BMC
Subjects:	Activities of daily living Aging Biochemical markers Body composition Body mass index Care and treatment Chronic kidney failure Cognition & reasoning Cognitive ability Cohort analysis Creatinine Diabetes Dialysis Dietary intake Elderly patients End stage renal disease Fibroblast growth factor 23 Fragility Frailty Geriatrics Glomerular filtration rate Hemodialysis Hypotheses Informed consent Kidney diseases Kidney research Klotho protein Medicin och hälsovetenskap Methods Mortality Nephrology Nephropathy Nutritional status Older people Outpatient care facilities Overweight Patients Prognosis Quality of life Questionnaires Renal replacement therapy Sleep Sleep disorders Study Protocol Survival Brazil Sleep Mortality Cognition Dialysis Renal replacement therapy End stage renal disease Fragility
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Summary:	Renal replacement therapy (RRT) is usually indicated for patients with chronic kidney disease (CKD) with glomerular filtration rate below 10 ml/ml/min/1.73m . However, the need for RRT and timing of dialysis initiation are debatable for patients aged 70 years or older. We here describe the study design and methodology of the Aging Nephropathy Study (AGNES) protocol that aims at evaluating to what extent geriatric-related conditions such as frailty, cognitive dysfunction, and presence of comorbidities have an impact on survival and RRT initiation in this group of patients. In this manuscript we provide detailed information about the AGNES study design and methodology. AGNES is a prospective observational cohort that aim to investigate clinical, biochemical and demographic factors associated with RRT initiation and mortality of patients with CKD stage 4 or 5 who are aged 70 years and older. We plan to include 200 patients over 5 years. Clinically stable outpatients on conservative management for at least 6 months will be recruited from the Nephrogeriatric Clinic at the Hospital das Clinicas da Universidade de Sao Paulo, Brazil. Eligible patients are submitted to a full clinical examination, geriatric assessment, and blood test at baseline. Following the baseline visit the patients are being monitored during an observational follow up period of at least 12 months during which patients will be contacted in the clinic at their regular follow up or by phone until either RRT initiation or death occurs. This cohort includes evaluation of cognition by the education-adjusted 10-point Cognitive Screener (10-CS), frailty by Fried index score, a complete nutritional assessment (by body composition assessment, global subjective assessment and dietary intake), comorbidities by Charlson comorbidity index and biochemical markers including FGF-23 and Klotho. The AGNES cohort, a real-world study of current clinical practice in elderly patients with advanced CKD prior to dialysis initiation, will shed light into progression of CKD and its complications, indications of RRT and factors determining survival. This investigation will elucidate to what extent geriatric conditions, nutritional status and clinical factors are associated with survival, quality of life and RRT initiation in elderly CKD patients not yet on dialysis. Registered on ClinicalTrials.gov on 18 October 2019 ( NCT04132492 ).
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1471-2369 1471-2369
DOI:	10.1186/s12882-020-02116-w