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

Hypertension Clinical Trial

— AURA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05690009
• Other study ID #: AURA
• Status: Recruiting
• Start date: February 27, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Eurasian Association of Therapists
• Contact: Elena Semenova, PhD
• Phone: +7 950 956 30 18
• Email: elena.semenova.md[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Albuminuria
• Atrial Fibrillation
• Cancer
• Chronic Heart Failure
• Chronic Kidney Diseases
• Chronic Obstructive Pulmonary Disease
• Coronary Artery Disease
• COVID-19
• Hypertension
• Ischemic Heart Disease
• Kidney Diseases
• Lung Diseases, Obstructive
• Myocardial Ischemia
• PreDiabetes
• Pulmonary Disease, Chronic Obstructive
• Renal Insufficiency, Chronic
• Urolithiasis

Locations

Country	Name	City	State
Russian Federation	Eurasian Association of Therapists	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Eurasian Association of Therapists

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of AU and its severity.		Day 1
Secondary	Number of comorbidities per patient with AU.		Day 1
Secondary	Frequency of prescribing renoprotective drugs.		Day 1
Secondary	Calculation of eGFR according to CKD-EPI formula 2021 in different phenotypes from the study population.		Day 1
Secondary	Prevalence of probable CKD in the study sample based on the clinical and laboratory data obtained during the screening.		Day 1