AGNES - Aging Nephropathy Study, a Prospective Observational Cohort of Chronic Kidney Disease in Elderly Patients
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Mortality [through study completion, an average of 2 years]
All-cause mortality
- Renal replacement therapy initiation [through study completion, an average of 2 years]
Start of hemodialysis or peritoneal dialysis
Secondary Outcome Measures
- Fragility [through study completion, an average of 2 years]
measured by Frailty scale
- Sleep disorder based on polysomnography [through study completion, an average of 2 years]
polysomnography
- Sleep disorder - somnolence [through study completion, an average of 2 years]
Epworth sleepiness scale
- Sleep disorder - subjective quality of sleep [through study completion, an average of 2 years]
pittsburgh questionnaire
- Sleep disorder - objective quality of sleep [through study completion, an average of 2 years]
actigraphy
- Cognition [through study completion, an average of 2 years]
Montreal Cognitive Assessment
- Nutrition [through study completion, an average of 2 years]
serum albumin
- Nutrition [through study completion, an average of 2 years]
cuff circimference
- Nutrition [through study completion, an average of 2 years]
body mass index
- Nutrition [through study completion, an average of 2 years]
bioimpedance analysis
- Mineral and bone markers [through study completion, an average of 2 years]
serum biomarkers
Eligibility Criteria
Criteria
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Clinical diagnosis of Chronic Kidney Disease stage 4 or 5
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Minimal age of 70 years
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Must be able to understand and sign the consent form
Exclusion Criteria:
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Patients who did not accept and sign the consent form
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Patients with cancer and life expectance lower than 6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital das Clinicas | Sao Paulo | SP | Brazil | 05403-000 |
| 2 | Unersidade de São Paulo | São Paulo | Brazil | 05410002 |
Sponsors and Collaborators
- University of Sao Paulo General Hospital
Investigators
- Principal Investigator: Rosilene Elias, MD, Ph.D., University of Sao Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AGNES