Bringing Knowledge About Chronic Kidney Disease in Brazil... | NCT07103629

Studies
Bringing Knowledge About Chronic Kidney Disease in Brazil: Filling the Gap

NCT07103629

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Oct 8, 2025Actual

Enrollment

8,428Actual

Phase

Not provided

Conditions

Renal Insufficiency, Chronic

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 31, 2025Actual

Primary Completion Date

Sep 30, 2025Actual

Completion Date

Sep 30, 2025Actual

First Submitted Date

Jul 29, 2025

First Submission Date that Met QC Criteria

Jul 29, 2025

First Posted Date

Aug 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2025

Last Update Posted Date

Oct 8, 2025Actual

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8,428Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Through study completation, an avarege 1 year

Secondary Outcomes

Measure	Description	Time Frame
Regional CKD potential prevalence	To evaluate regional differences regarding CKD prevalence	Through study completation, an avarege 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years old
At least one risk factor for CKD as mentioned above.

Exclusion Criteria:

Patients with previous diagnosis of CKD
Patients younger than 18 years old
Patients unable to give informed consent to participate in the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Viviane da Silva	Sociedade Brasileira de Nefrologia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sociedade Brasileira de Nefrologia		São Paulo		04044-000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

URL

https://vivli.org/

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

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Browse Branches

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