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

August 27, 2024 updated by: Eurasian Association of Therapists
Real clinical practice register of Albuminuria detection in patients with previously undiagnosed chronic kidney disease

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

4580

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of AU and its severity.
Time Frame: Day 1
Determination of AU by qualitative and/or quantitative methods
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of comorbidities per patient with AU.
Time Frame: Day 1
Number of comorbidities per patient with AU.
Day 1
Frequency of prescribing renoprotective drugs.
Time Frame: 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.
Time Frame: 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.
Time Frame: Day 1
Prevalence of probable CKD in the study sample based on the clinical and laboratory data obtained during the screening.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eurasian Association of Therapists

Investigators

  • Study Chair: Alexander Arutyunov, professor, Eurasian Association of Internal Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2023

Primary Completion (Actual)

January 23, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

December 29, 2022

First Submitted That Met QC Criteria

January 15, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AURA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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