To Determine the Accuracy of SCreening for Occult REnal Disease (SCORED) Questionnaire for CKD Risk Among Asian Patients (SCREEN)

March 12, 2024 updated by: AstraZeneca

A Real-World Multicentre Prospective Study to Determine the Accuracy of the SCORED (SCreening for Occult REnal Disease) Questionnaire for SCreening REnal Risk Early Against Nephropathy in Adult Population in Asia

To determine the accuracy of SCreening for Occult REnal Disease (SCORED) questionnaire for CKD risk among Asian Patients

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

1426

Contacts and Locations

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

Study Contact

Study Locations

  • Indonesia
      • Surabaya, Indonesia
        • Research Site
    • Jawa Barat
      • Bandung, Jawa Barat, Indonesia, 40115
        • Perisai Husada
  • Vietnam
      • Ho Chi Minh City, Vietnam, 70000
        • Nguyen Tri Phuong Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Normal Adult Population in Asia

Description

Inclusion Criteria:

-

Exclusion Criteria:

-

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity
Time Frame: 28 February 2024
The primary objective is to evaluate the accuracy of SCORED tool in identifying individuals at risk for the development of CKD in the Asian population. The primary outcomes, sensitivity, and specificity will be summarised using percentage and 95% confidence intervals to be measured at Baseline up to 6months after enrollment
28 February 2024

Collaborators and Investigators

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

Sponsor

AstraZeneca

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)

June 22, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 10, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1843R00353

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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