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

Astellas

Status: Completed

Conditions: Chronic Kidney Disease (CKD)

Treatments: Other: Non-interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT04042350

1517-MA-3256

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,773 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,773 participants in 1 patient group

CKD patients on dialysis

Description:

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

Treatment:

Other: Non-interventional