Clinical trial NCT05690009: Real Clinical Practice Register of AlbUminuRia Detection in Patients With Previously undiAgnosed Chronic Kidney Disease
Official title: Real Clinical Practice Register of AlbUminuRia Detection in Patients With Previously undiAgnosed Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Hypertension
Chronic Heart Failure
Ischemic Heart Disease
Atrial Fibrillation
PreDiabetes
Chronic Obstructive Pulmonary Disease
Cancer
Urolithiasis
COVID-19
Keywords: Albumin-to-creatinine ratio
Albuminuria
Microalbuminuria
Chronic Kidney Diseases
Estimation of glomerular filtration rate
Lead sponsor: Eurasian Association of Therapists
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 4580
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 40 or older without preexisting diagnoses of chronic kidney disease, type 1 diabetes, and type 2 diabetes will be enrolled into this register.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of AU and its severity.
timeFrame: Day 1
Secondary outcomes:
measure: Number of comorbidities per patient with AU.
timeFrame: Day 1
measure: Frequency of prescribing renoprotective drugs.
timeFrame: Day 1
measure: Calculation of eGFR according to CKD-EPI formula 2021 in different phenotypes from the study population.
timeFrame: Day 1
measure: Prevalence of probable CKD in the study sample based on the clinical and laboratory data obtained during the screening.
timeFrame: Day 1
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Eurasian Association of Therapists
Study officials:
affiliation: Eurasian Association of Internal Medicine
name: Alexander Arutyunov, professor
role: STUDY_CHAIR
References: