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

Sponsor

Eurasian Association of Therapists (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05690009

Collaborator

(none)

12,000

Enrollment

Location

11.3

Anticipated Duration (Months)

1058.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases Hypertension Chronic Heart Failure Ischemic Heart Disease Atrial Fibrillation PreDiabetes Chronic Obstructive Pulmonary Disease Cancer Urolithiasis COVID-19

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

12000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 20, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Prevalence of AU and its severity. [Day 1]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

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.