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

Chronic Kidney Disease (CKD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042350
• Other study ID #: 1517-MA-3256
• Status: Completed
• Start date: May 22, 2019
• Est. completion date: February 19, 2020

Study information

• Verified date: December 2020
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2773
• Est. completion date: February 19, 2020
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD)
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Non-interventional
Exploring clinical risk factors associated with the risk for cardiovascular events and mortality, rather than to evaluate specific drugs.

Locations

Country	Name	City	State
Sweden	Site SE46001	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe Ltd.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to CV event: MI	Time to individual CV event.	Up to a maximum of 5.6 years
Secondary	Time to CV event: stroke (ischemic or hemorrhagic)	Time to individual CV event.	Up to a maximum of 5.6 years
Secondary	Time to CV event: unstable angina	Time to individual CV event.	Up to a maximum of 5.6 years
Secondary	Time to CV event: coronary revascularization therapy	Time to individual CV event.	Up to a maximum of 5.6 years
Secondary	Time to CV event: new onset heart failure	Time to individual CV event.	Up to a maximum of 5.6 years
Secondary	Time to CV mortality	Time to death caused by a CV event.	Up to a maximum of 5.6 years
Secondary	Time to all-cause mortality	Time to death from any cause.	Up to a maximum of 5.6 years

External Links

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