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

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ClinicalTrials.gov Identifier: NCT04132492
Recruitment Status : Recruiting
First Posted : October 18, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
Chronic Kidney Diseases Elderly Mortality Renal Replacement Therapy

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AGNES - Aging Nephropathy Study, a Prospective Observational Cohort of Chronic Kidney Disease in Elderly Patients
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases




Primary Outcome Measures :
  1. Mortality [ Time Frame: through study completion, an average of 2 years ]
    All-cause mortality

  2. Renal replacement therapy initiation [ Time Frame: through study completion, an average of 2 years ]
    Start of hemodialysis or peritoneal dialysis


Secondary Outcome Measures :
  1. Fragility [ Time Frame: through study completion, an average of 2 years ]
    measured by Frailty scale

  2. Sleep disorder based on polysomnography [ Time Frame: through study completion, an average of 2 years ]
    polysomnography

  3. Sleep disorder - somnolence [ Time Frame: through study completion, an average of 2 years ]
    Epworth sleepiness scale

  4. Sleep disorder - subjective quality of sleep [ Time Frame: through study completion, an average of 2 years ]
    pittsburgh questionnaire

  5. Sleep disorder - objective quality of sleep [ Time Frame: through study completion, an average of 2 years ]
    actigraphy

  6. Cognition [ Time Frame: through study completion, an average of 2 years ]
    Montreal Cognitive Assessment

  7. Nutrition [ Time Frame: through study completion, an average of 2 years ]
    serum albumin

  8. Nutrition [ Time Frame: through study completion, an average of 2 years ]
    cuff circimference

  9. Nutrition [ Time Frame: through study completion, an average of 2 years ]
    body mass index

  10. Nutrition [ Time Frame: through study completion, an average of 2 years ]
    bioimpedance analysis

  11. Mineral and bone markers [ Time Frame: through study completion, an average of 2 years ]
    serum biomarkers


Biospecimen Retention:   Samples Without DNA
Blood and plasma


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Outpatients with CKD that have been followed in the nephrology service - Nephrogeriatric ambulatory
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132492


Contacts
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Contact: Rosilene Elias, MD, Ph.D. +5511981875578 rosilenemotta@hotmail.com

Locations
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Brazil
Hospital das Clinicas Recruiting
Sao Paulo, SP, Brazil, 05403-000
Contact: Rosilene M Elias, M.D, Ph.D    +5511 2661-7167    rosilenemotta@hotmail.com   
Principal Investigator: Rosilene M Elias, M.D., Ph.D         
Unersidade de São Paulo Recruiting
São Paulo, Brazil, 05410002
Contact: Rosilene Elias, MD. Ph.D.    11981875578    rosilenemotta@hotmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Rosilene Elias, MD, Ph.D. University of Sao Paulo

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04132492     History of Changes
Other Study ID Numbers: AGNES
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency