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

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

Sponsors

Lead sponsor: University of Sao Paulo General Hospital

Source University of Sao Paulo General Hospital
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

Overall Status Recruiting
Start Date September 1, 2019
Completion Date December 30, 2022
Primary Completion Date September 30, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Mortality through study completion, an average of 2 years
Renal replacement therapy initiation through study completion, an average of 2 years
Secondary Outcome
Measure Time Frame
Fragility through study completion, an average of 2 years
Sleep disorder based on polysomnography through study completion, an average of 2 years
Sleep disorder - somnolence through study completion, an average of 2 years
Sleep disorder - subjective quality of sleep through study completion, an average of 2 years
Sleep disorder - objective quality of sleep through study completion, an average of 2 years
Cognition through study completion, an average of 2 years
Nutrition through study completion, an average of 2 years
Nutrition through study completion, an average of 2 years
Nutrition through study completion, an average of 2 years
Nutrition through study completion, an average of 2 years
Mineral and bone markers through study completion, an average of 2 years
Enrollment 500
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

- Clinical diagnosis of Chronic Kidney Disease stage 4 or 5

- Minimal age of 70 years

- Must be able to understand and sign the consent form

Exclusion Criteria:

- Patients who did not accept and sign the consent form

- Patients with cancer and life expectance lower than 6 months

Gender: All

Minimum age: 70 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Rosilene Elias, MD, Ph.D. Principal Investigator University of Sao Paulo
Overall Contact

Last name: Rosilene Elias, MD, Ph.D.

Phone: +5511981875578

Email: [email protected]

Location
facility status contact investigator
Hospital das Clinicas | Sao Paulo, SP, 05403-000, Brazil Recruiting Rosilene M Elias, M.D, Ph.D +5511 2661-7167 [email protected] Rosilene M Elias, M.D., Ph.D Principal Investigator
Unersidade de São Paulo | São Paulo, 05410002, Brazil Recruiting Rosilene Elias, MD. Ph.D. 11981875578 [email protected]
Location Countries

Brazil

Verification Date

October 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Acronym AGNES
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov