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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04132492
Other study ID # AGNES
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date December 30, 2024

Study information

Verified date October 2023
Source University of Sao Paulo General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Main outcome: combined event mortality-dialysis Independent variables: nutrition status, sleep quality, Klotho and FGF-23 Confounders: clinical and demographic variables, Charlson comorbidity index, Laboratory parameters, depression, functionality, cognition.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 500
Est. completion date December 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility - 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 - Moderate to advanced dementia

Study Design


Intervention

Other:
no intervention
there is no intervention

Locations

Country Name City State
Brazil Hospital das Clinicas Sao Paulo SP
Brazil Unersidade de São Paulo São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Combined events mortality-dialysis dialysis or death through study completion, an average of 2 years
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