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Completed

NCT Number: NCT05690009

Real Clinical Practice Register of AlbUminuRia Detection in Patients With Previously undiAgnosed Chronic Kidney Disease

Real clinical practice register of Albuminuria detection in patients with previously undiagnosed chronic kidney disease

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Key information

Conditions

Chronic Kidney Diseases Albuminuria Arrhythmias, Cardiac Atrial Fibrillation COVID-19 Cancer Cardiovascular Diseases Chronic Disease Chronic Heart Failure Chronic Obstructive Pulmonary Disease Coronaviridae Infections Coronavirus Infections Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Heart Diseases Hypertension Infections Ischemic Heart Disease Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Metabolic Diseases Myocardial Ischemia Neoplasms Nidovirales Infections Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral PreDiabetes Prediabetic State Proteinuria Pulmonary Disease, Chronic Obstructive RNA Virus Infections Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Urination Disorders Urogenital Diseases Urolithiasis Urologic Diseases Urological Manifestations Vascular Diseases Virus Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eurasian Association of Therapists

Moscow, Russia

About this study

This register was sponsored and organized by the Association "Eurasian Association of Internal Medicine". It is a multicenter non-interventional register of real clinical practice. The database will include patients aged 40 years and older without pre-existing nephrological disease who are available for a dipstick test for albuminuria. The subjects will be identified by screening all patients who meet inclusion/exclusion criteria during routine outpatient and hospital follow-up. The register does not include follow-up (cross-sectional design).

Patients eligible for the register should be enrolled and documented. The procedure for obtaining informed consent for the collection and analysis of the retrospective data must comply with the local legislation. If necessary, patients will be asked to sign an informed consent document.

All study sites will use standardized electronic CRFs. The Electronic Data Capture (EDC) system should be validated in accordance with current standards and legal requirements. The investigators will log into this system using individual usernames and passwords. Data may only be entered and corrected by the investigator or other authorized study site personnel.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women aged 40 and older at the time of data entry;
  • A possibility to check for albuminuria using dipsticks and/or analysis for microalbuminuria or albumin-to-creatinine ratio in a single urine sample.

Exclusion criteria

  • Unwillingness of the patient to participate in the register;
  • Diagnosis of CKD made before the screening for the register;
  • Diagnosis of diabetes mellitus (DM) type 1 or type 2 made before the screening for the register;
  • Pregnancy;
  • Long distance running or very strenuous physical activity in the last 24 hours.

Treatment and study plan

Primary outcomes

  1. Prevalence of AU and its severity.

    Time frame: Day 1

    Determination of AU by qualitative and/or quantitative methods

Secondary outcomes

  1. Number of comorbidities per patient with AU.

    Time frame: Day 1

    Number of comorbidities per patient with AU.

  2. Frequency of prescribing renoprotective drugs.

    Time frame: Day 1

    Frequency of prescribing renoprotective drugs.

  3. Calculation of eGFR according to CKD-EPI formula 2021 in different phenotypes from the study population.

    Time frame: Day 1

    Calculation of eGFR according to CKD-EPI formula 2021 in different phenotypes from the study population.

  4. Prevalence of probable CKD in the study sample based on the clinical and laboratory data obtained during the screening.

    Time frame: Day 1

    Prevalence of probable CKD in the study sample based on the clinical and laboratory data obtained during the screening.

Sponsors and collaborators

Lead sponsor

Eurasian Association of Therapists

Other

Registry information

Acronym: AURA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2023
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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