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

NCT07103629 | Completed

• 1 other identifier: D1691R00003
• Study Type: observational
• Target: 8,428
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency, Chronic

Keywords

chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Regional CKD potential prevalence

  Through study completation, an avarege 1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Sociedade Brasileira de Nefrologia

São Paulo, 04044-000, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

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

Study Officials

• Viviane da Silva

  Sociedade Brasileira de Nefrologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: May 31, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

BR (1)