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

Overview

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

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2023

Detailed Description

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.

Arms, Groups and Cohorts

  • Patients with albuminuria
    • Patients aged 40 or older without preexisting diagnoses of chronic kidney disease, type 1 diabetes, and type 2 diabetes with positive albuminuria by dipsticks and/or microalbuminuria test or albumin-to-creatinine ratio in a single urine sample.

Clinical Trial Outcome Measures

Primary Measures

  • Prevalence of AU and its severity.
    • Time Frame: Day 1

Secondary Measures

  • Number of comorbidities per patient with AU.
    • Time Frame: Day 1
  • Frequency of prescribing renoprotective drugs.
    • Time Frame: Day 1
  • Calculation of eGFR according to CKD-EPI formula 2021 in different phenotypes from the study population.
    • Time Frame: Day 1
  • Prevalence of probable CKD in the study sample based on the clinical and laboratory data obtained during the screening.
    • Time Frame: Day 1

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Eurasian Association of Therapists
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alexander Arutyunov, professor, Study Chair, Eurasian Association of Internal Medicine
  • Overall Contact(s)
    • Elena Semenova, PhD, +7 950 956 30 18, elena.semenova.md@gmail.com

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