Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-01-03 @ 7:39 AM
Study NCT ID:
NCT04042350
Status:
COMPLETED
Last Update Posted:
2024-10-31
First Post:
2019-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Astellas Pharma Europe Ltd.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: