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

NCT05690009 | Completed DMC

• 1 other identifier: AURA
• Study Type: observational
• Target: 4,580
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Prevalence of AU and its severity.

  Determination of AU by qualitative and/or quantitative methods

  Day 1

Secondary Outcomes (4)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurasian Association of Therapists: lead

Study Sites (1)

Eurasian Association of Therapists

Moscow, Russia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension; Myocardial Ischemia; Atrial Fibrillation; Prediabetic State; Pulmonary Disease, Chronic Obstructive; Neoplasms; Urolithiasis; COVID-19; Albuminuria

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arrhythmias, Cardiac; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms

Study Officials

• Alexander Arutyunov, professor

  Eurasian Association of Internal Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 19, 2023
• Study Start: February 27, 2023
• Primary Completion: January 23, 2024
• Study Completion: April 1, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)