Clinical trial NCT04042350: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease (CKD)
Keywords: AURORA
Cardiovascular Events
Chronic Kidney Disease
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2019-08-01
Enrollment: 2773
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to first major adverse cardiovascular event (MACE)
timeFrame: Up to a maximum of 5.6 years
Secondary outcomes:
measure: Time to a composite of any CV events
timeFrame: Up to a maximum of 5.6 years
measure: Time to CV event: MI
timeFrame: Up to a maximum of 5.6 years
measure: Time to CV event: stroke (ischemic or hemorrhagic)
timeFrame: Up to a maximum of 5.6 years
measure: Time to CV event: unstable angina
timeFrame: Up to a maximum of 5.6 years
measure: Time to CV event: coronary revascularization therapy
timeFrame: Up to a maximum of 5.6 years
measure: Time to CV event: new onset heart failure
timeFrame: Up to a maximum of 5.6 years
measure: Time to CV mortality
timeFrame: Up to a maximum of 5.6 years
measure: Time to all-cause mortality
timeFrame: Up to a maximum of 5.6 years
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Site SE46001
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Central Contact
role: STUDY_DIRECTOR
References: