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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease (CKD)
• Intervention / Treatment: Other: Non-interventional

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.

• Study Type: Observational
• Enrollment (Actual): 2773

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, SE-75185
    • Site SE46001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients included in the AURORA study were men and women who had ESRD and had been treated with regular hemodialysis or hemofiltration for at least 3 months.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe Ltd.

Publications and helpful links

Helpful Links

• Link to results on the Astellas Clinical Study Results website.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2019
• Primary Completion (ACTUAL): February 19, 2020
• Study Completion (ACTUAL): February 19, 2020

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (ACTUAL): August 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 6, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Cardiovascular Events; AURORA
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 1517-MA-3256

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No