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 Overview
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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.

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.

Official Title
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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

Conditions
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Chronic Kidney Disease (CKD)

Intervention / Treatment
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* Other: Non-interventional


Participation Criteria
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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). Exclusion Criteria: The major exclusion criteria in AURORA were statin therapy within the previous 6 months, expected kidney transplantation within 1 year, and serious hematologic, neoplastic, gastrointestinal, infectious, or metabolic disease (excluding diabetes) that was predicted to limit life expectancy to less than 1 year. Other exclusion criteria were a history of a malignant condition, active liver disease (indicated by an alanine aminotransferase level that was more than three times the upper limit of the normal range), uncontrolled hypothyroidism, and an unexplained elevation in the creatine kinase level to more than three times the upper limit of the normal range.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CKD patients on dialysis<br>Data will be analyzed from CKD patients on dialysis that participated in the AURORA study. | Other: Non-interventional<br>* Exploring clinical risk factors associated with the risk for cardiovascular events and mortality, rather than to evaluate specific drugs.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AURORA, Cardiovascular Events, Chronic Kidney Disease