A Study to Evaluate the ePidemiology of anEmia Associated With chroNic Kidney Disease in Patients in Primary Care Using The Stockholm CREAtinine Measurement (SCREAM) Register

NCT ID: NCT05015998

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

45637 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-30

Study Completion Date

2021-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objectives of this analysis is to determine the incidence of anemia occurring in patients with chronic kidney disease (CKD) in primary care (i.e. prior to any eventual referral to nephrology care). This analysis also evaluates patient characteristics, anemia treatment and associated cardiovascular risk.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Data will be derived from the Stockholm CREATinine Measurement (SCREAM) cohort, a repository of laboratory data of individuals residing and accessing healthcare in the region of Stockholm and who underwent a creatinine assessment between 2012 - 2018.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Non-dialysis dependent patients with CKD stage 3-5

A cohort of patients will be created from the Stockholm CREAtinine Measurement (SCREAM) cohort based on the eligibility criteria.

Non-interventional

Intervention Type OTHER

Epidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non-interventional

Epidemiology of anemia associated with chronic kidney disease, rather than to evaluate specific drugs

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient entered in SCREAM between 2012 and 2018
* With two consecutive plasma-creatinine test(s) indicating an estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m\^2
* With at least one eligible Hb after eGFR \< 60 mL/min/1.73 m\^2. The date of the first eligible Hb test is the study entry point/index date of the study.

Exclusion Criteria

* Patient who has had a recent pregnancy or childbirth (issued diagnosis within 2 years prior to index date).
* Patient with ongoing/recent cancer (diagnosed within the previous 3 years), haematological diseases or leukaemia.
* Patient with chronic infections (hepatitis, tuberculosis, or human immunodeficiency virus \[HIV\]); note by definition chronic infections are chronic and look back period will be to 1997.
* Patients with anemia at baseline (index date), defined by an anemia diagnosis in the year prior, a baseline Hb value within the anemia range according to the WHO definition, or the presence of a recent dispensation of ESA or iron (up to six months prior).
* Patient referred to nephrologist within the previous 2 years from cohort entry/ index date.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Astellas Pharma Europe Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Europe Ltd.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SE46001

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Related Links

Access external resources that provide additional context or updates about the study.

https://www.clinicaltrials.astellas.com/study/1517-MA-1569/

Link to results on the Astellas Clinical Study Results website.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1517-MA-1569

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Primary Care CKD Registry
NCT03473509 COMPLETED NA