Chronic Kidney DiseasesAURANCT05690009
Real Clinical Practice Register of AlbUminuRia Detection in Patients With Previously undiAgnosed Chronic Kidney Disease
An observational study of Chronic Kidney Diseases and Hypertension, run by Eurasian Association of Therapists at 1 site in Russia.
Trial summary
Real clinical practice register of Albuminuria detection in patients with previously undiagnosed chronic kidney disease Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Hypertension, Chronic Heart Failure
- How many people
- 4,580 participants
- Where
- 1 siteRussia
- Study dates
- 27 Feb 2023to 1 Apr 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Real clinical practice register of Albuminuria detection in patients with previously undiagnosed chronic kidney disease
Read the 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.
- Conditions
- Chronic Kidney Diseases, Hypertension, Chronic Heart Failure, Ischemic Heart Disease, Atrial Fibrillation, PreDiabetes
- Keywords
- Albumin-to-creatinine ratio, Albuminuria, Microalbuminuria, Chronic Kidney Diseases, Estimation of glomerular filtration rate
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension, Myocardial Ischemia, Atrial Fibrillation, Prediabetic State, Pulmonary Disease, Chronic Obstructive, Neoplasms, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of AU and its severity.
Determination of AU by qualitative and/or quantitative methods
Measured: Day 1
Secondary outcomes (4)
Number of comorbidities per patient with AU.
Number of comorbidities per patient with AU.
Measured: Day 1
Frequency of prescribing renoprotective drugs.
Frequency of prescribing renoprotective drugs.
Measured: Day 1
Calculation of eGFR according to CKD-EPI formula 2021 in different phenotypes from the study population.
Calculation of eGFR according to CKD-EPI formula 2021 in different phenotypes from the study population.
Measured: Day 1
Prevalence of probable CKD in the study sample based on the clinical and laboratory data obtained during the screening.
Prevalence of probable CKD in the study sample based on the clinical and laboratory data obtained during the screening.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start27 Feb 2023
- Primary completion23 Jan 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,580 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Eurasian Association of Therapists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Arutyunov, professor, Study chair, Eurasian Association of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690009
- Sponsor's protocol ID
- AURA
- Acronym
- AURA
- Status last verified
- Aug 2024
- First submitted
- 29 Dec 2022
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Clinical Practice Register of AlbUminuRia Detection in Patients With Previously undiAgnosed Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05690009
- Acronym / sponsor ID
- AURA / AURA
- Conditions
- Chronic Kidney Diseases, Hypertension, Chronic Heart Failure, Ischemic Heart Disease, Atrial Fibrillation, PreDiabetes
- Keywords
- Albumin-to-creatinine ratio, Albuminuria, Microalbuminuria, Chronic Kidney Diseases, Estimation of glomerular filtration rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,580 participants (actual)
- Lead sponsor
- Eurasian Association of TherapistsUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of AU and its severity.
Time frame: Day 1
Determination of AU by qualitative and/or quantitative methods
4 secondary outcomes
Number of comorbidities per patient with AU.
Time frame: Day 1
Frequency of prescribing renoprotective drugs.
Time frame: Day 1
Calculation of eGFR according to CKD-EPI formula 2021 in different phenotypes from the study population.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Arutyunov, professor study chair
Eurasian Association of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Hypertension, run by Eurasian Association of Therapists at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of AU and its severity. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.