Status:
COMPLETED
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
Lead Sponsor:
Astellas Pharma Europe Ltd.
Conditions:
Chronic Kidney Disease (CKD)
Eligibility:
All Genders
50-80 years
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 ...
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 prospecti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 19 2020
Estimated Enrollment :
2773 Patients enrolled
Trial Details
Trial ID
NCT04042350
Start Date
May 22 2019
End Date
February 19 2020
Last Update
October 31 2024
Active Locations (1)
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1
Site SE46001
Uppsala, Sweden, SE-75185