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
1 other identifier
observational
2,773
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 22, 2019
CompletedFirst Submitted
Initial submission to the registry
July 31, 2019
CompletedFirst Posted
Study publicly available on registry
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 19, 2020
CompletedOctober 31, 2024
October 1, 2024
9 months
July 31, 2019
October 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Time to a composite of any CV events
Up to a maximum of 5.6 years
Time to CV event: MI
Up to a maximum of 5.6 years
Time to CV event: stroke (ischemic or hemorrhagic)
Up to a maximum of 5.6 years
Time to CV event: unstable angina
Up to a maximum of 5.6 years
Time to CV event: coronary revascularization therapy
Up to a maximum of 5.6 years
- +3 more secondary outcomes
Study Arms (1)
CKD patients on dialysis
Data will be analyzed from CKD patients on dialysis that participated in the AURORA study.
Interventions
Exploring clinical risk factors associated with the risk for cardiovascular events and mortality, rather than to evaluate specific drugs.
Eligibility Criteria
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.
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Site SE46001
Uppsala, SE-75185, Sweden
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Europe Ltd.
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2019
First Posted
August 1, 2019
Study Start
May 22, 2019
Primary Completion
February 19, 2020
Study Completion
February 19, 2020
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.