Retrospective Analysis Assessing Clinical Risk Factors for Cardiovascular Events and Mortality and Development of a Risk Calculator in Chronic Kidney Disease Stage 5 on Dialysis

A Retrospective Analysis Assessing Clinical Risk Factors for Cardiovascular Events and Mortality and Development of a Risk Calculator in Chronic Kidney Disease Stage 5 on Dialysis Treatment Using Data From the AURORA Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04042350

Enrollment

2773

Registered

2019-08-01

Start date

2019-05-22

Completion date

2020-02-19

Last updated

2024-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease (CKD)

Keywords

AURORA, Cardiovascular Events, Chronic Kidney Disease

Brief summary

The purpose of this study is to evaluate which clinical and laboratory factors are associated with major adverse cardiovascular event (MACE) in chronic kidney disease (CKD) patients on dialysis. The study will also establish a cardiovascular (CV) risk equation appropriate for this dialysis population.

Detailed description

This study is a retrospective analysis of dialysis dependent CKD patients participating in AURORA. The retrospective analysis will be performed using the AURORA study database. AURORA was a prospective clinical trial in which dialysis patients were randomly assigned to rosuvastatin or placebo, sponsored by AstraZeneca. Patients included in the AURORA study who had end stage renal disease (ESRD) and had been treated with regular hemodialysis or hemofiltration for at least 3 months. Patients were recruited from approximately 300 centers in 25 countries. The clinical study data is held by AstraZeneca AB, Sweden. No formal sample size calculation was performed. The sample size is based on the available data from the AURORA study.

Interventions

OTHERNon-interventional

Exploring clinical risk factors associated with the risk for cardiovascular events and mortality, rather than to evaluate specific drugs.

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients who participated in the AURORA study. In brief, men and women who had ESRD and had been treated with regular hemodialysis or hemofiltration for at least 3 months (patients were recruited from 280 centers in 25 countries).

Exclusion criteria

* The major

Design outcomes

Primary

Measure	Time frame	Description
Time to first major adverse cardiovascular event (MACE)	Up to a maximum of 5.6 years	A MACE is defined as a non-fatal myocardial infarction (MI), non-fatal stroke, and CV mortality.

Secondary

Measure	Time frame	Description
Time to CV event: MI	Up to a maximum of 5.6 years	Time to individual CV event.
Time to CV event: stroke (ischemic or hemorrhagic)	Up to a maximum of 5.6 years	Time to individual CV event.
Time to CV event: unstable angina	Up to a maximum of 5.6 years	Time to individual CV event.
Time to a composite of any CV events	Up to a maximum of 5.6 years	CV events include non-fatal MI, unstable angina, coronary revascularization therapy, new onset heart failure, non-fatal stroke or all-cause mortality.
Time to CV event: new onset heart failure	Up to a maximum of 5.6 years	Time to individual CV event.
Time to CV mortality	Up to a maximum of 5.6 years	Time to death caused by a CV event.
Time to all-cause mortality	Up to a maximum of 5.6 years	Time to death from any cause.
Time to CV event: coronary revascularization therapy	Up to a maximum of 5.6 years	Time to individual CV event.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026