Renal Insufficiency, ChronicFilling gapNCT07103629
Bringing Knowledge About Chronic Kidney Disease in Brazil: Filling the Gap
An observational study of Renal Insufficiency, Chronic, run by AstraZeneca at 1 site in Brazil.
Trial summary
This is a multicenter cross-sectional study will randomly screen kidney function in adult patients with known risk factors for chronic kidney disease (CKD) within the Brazilian general population. Kidney function will be assessed using a point-of-care creatinine test at local healthcare facilities. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Insufficiency, Chronic
- How many people
- 8,428 participants
- Where
- 1 siteBrazil
- Study dates
- 31 May 2025to 30 Sep 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: dult patients with at least one risk factor for Chronic Kidney Disease (CKD) listed as follows: 1) Arterial Hypertension (HTN); 2) Diabetes Mellitus (DM); 3) Cardiovascular disease (CVD); 4) Obesity (BMI ≥ 30 kg/m²); 4) Previous acute kidney injury (AKI); 5) previous history of bilateral renal lithiasis; 6) Chronic use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs); 7) Family history of genetic kidney disease. Only patients who agree to participate and sign an informed consent form will be included in the study.
Who may be able to join
- Age > 18 years old
- At least one risk factor for CKD as mentioned above.
Who cannot join
- Patients with previous diagnosis of CKD
- Patients younger than 18 years old
- Patients unable to give informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-sectional Study to Evaluate the Chronic Kidney Disease Prevalence Using a Creatinine Point-of-care Tool in Brazilian Adult Patients With Known CKD Risk Factors Randomly Selected
This is a multicenter cross-sectional study will randomly screen kidney function in adult patients with known risk factors for chronic kidney disease (CKD) within the Brazilian general population. Kidney function will be assessed using a point-of-care creatinine test at local healthcare facilities. Patients with abnormal test results will be referred for laboratory confirmation within three months and will undergo evaluation by the local nephrology team to determine the need for follow-up care.
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
CKD potential prevalence
To estimate the prevalence of Chronic Kidney Disease (CKD) in Brazil through random screening using a portable device for creatinine measurement and eGFR estimation in adult patients with risk factors for the development of CKD across the five regions of the country.
Measured: Through study completation, an avarege 1 year
Secondary outcomes (1)
Regional CKD potential prevalence
To evaluate regional differences regarding CKD prevalence
Measured: Through study completation, an avarege 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start31 May 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 8,428 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Viviane da Silva, Principal investigator, Sociedade Brasileira de Nefrologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103629
- Sponsor's protocol ID
- D1691R00003
- Acronym
- Filling gap
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Study to Evaluate the Chronic Kidney Disease Prevalence Using a Creatinine Point-of-care Tool in Brazilian Adult Patients With Known CKD Risk Factors Randomly Selected
- ClinicalTrials.gov ID
- NCT07103629
- Acronym / sponsor ID
- Filling gap / D1691R00003
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,428 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 May 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 5 Aug 2025 (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.
This is a multicenter cross-sectional study will randomly screen kidney function in adult patients with known risk factors for chronic kidney disease (CKD) within the Brazilian general population. Kidney function will be assessed using a point-of-care creatinine test at local healthcare facilities. Patients with abnormal test results will be referred for laboratory confirmation within three months and will undergo evaluation by the local nephrology team to determine the need for follow-up care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- dult patients with at least one risk factor for Chronic Kidney Disease (CKD) listed as follows: 1) Arterial Hypertension (HTN); 2) Diabetes Mellitus (DM); 3) Cardiovascular disease (CVD); 4) Obesity (BMI ≥ 30 kg/m²); 4) Previous acute kidney injury (AKI); 5) previous history of bilateral renal lithiasis; 6) Chronic use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs); 7) Family history of genetic kidney disease. Only patients who agree to participate and sign an informed consent form will be included in the study.
Key inclusion criteria (2 listed)
- Age > 18 years old
- At least one risk factor for CKD as mentioned above.
Key exclusion criteria (3 listed)
- Patients with previous diagnosis of CKD
- Patients younger than 18 years old
- Patients unable to give informed consent to participate in the study.
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
CKD potential prevalence
Time frame: Through study completation, an avarege 1 year
To estimate the prevalence of Chronic Kidney Disease (CKD) in Brazil through random screening using a portable device for creatinine measurement and eGFR estimation in adult patients with risk factors for the development of CKD across the five regions of the country.
1 secondary outcome
Regional CKD potential prevalence
Time frame: Through study completation, an avarege 1 year
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 20 Oct 2026.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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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.
Viviane da Silva principal investigator
Sociedade Brasileira de Nefrologia
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 Renal Insufficiency, Chronic, run by AstraZeneca at 1 site in Brazil.
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 3 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 20 Oct 2026. 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 Brazil. 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?
CKD potential prevalence (time frame: Through study completation, an avarege 1 year). 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 20 Oct 2026.