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

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

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Recruitment Status

COMPLETED

Total Enrollment

2773 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-22

Study Completion Date

2020-02-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease (CKD)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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CKD patients on dialysis

Data will be analyzed from CKD patients on dialysis that participated in the AURORA study.

Non-interventional

Intervention Type OTHER

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

Interventions

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Non-interventional

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

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No