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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,773 (actual)
• Sponsor: Astellas Pharma Europe Ltd. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease (CKD)

Interventions

Type	Name	Description
OTHER	Non-interventional	Exploring clinical risk factors associated with the risk for cardiovascular events and mortality, rather than to evaluate specific drugs.

Timeline

• Start date: 2019-05-22
• Primary completion: 2020-02-19
• Completion: 2020-02-19
• First posted: 2019-08-01
• Last updated: 2024-10-31

Locations

1 site across 1 country: Sweden