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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. (Industry)
Overall Status
Completed
CT.gov ID
NCT04042350
Collaborator
(none)
2,773
Enrollment
1
Location
9
Actual Duration (Months)
309.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Non-interventional

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.

Study Design

Study Type:
Observational
Actual Enrollment :
2773 participants
Observational Model:
Other
Time Perspective:
Retrospective
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
Actual Study Start Date :
May 22, 2019
Actual Primary Completion Date :
Feb 19, 2020
Actual Study Completion Date :
Feb 19, 2020

Arms and Interventions

Arm Intervention/Treatment
CKD patients on dialysis

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

Other: Non-interventional
Exploring clinical risk factors associated with the risk for cardiovascular events and mortality, rather than to evaluate specific drugs.

Outcome Measures

Primary Outcome Measures

  1. Time to first major adverse cardiovascular event (MACE) [Up to a maximum of 5.6 years]

    A MACE is defined as a non-fatal myocardial infarction (MI), non-fatal stroke, and CV mortality.

Secondary Outcome Measures

  1. Time to a composite of any CV events [Up to a maximum of 5.6 years]

    CV events include non-fatal MI, unstable angina, coronary revascularization therapy, new onset heart failure, non-fatal stroke or all-cause mortality.

  2. Time to CV event: MI [Up to a maximum of 5.6 years]

    Time to individual CV event.

  3. Time to CV event: stroke (ischemic or hemorrhagic) [Up to a maximum of 5.6 years]

    Time to individual CV event.

  4. Time to CV event: unstable angina [Up to a maximum of 5.6 years]

    Time to individual CV event.

  5. Time to CV event: coronary revascularization therapy [Up to a maximum of 5.6 years]

    Time to individual CV event.

  6. Time to CV event: new onset heart failure [Up to a maximum of 5.6 years]

    Time to individual CV event.

  7. Time to CV mortality [Up to a maximum of 5.6 years]

    Time to death caused by a CV event.

  8. Time to all-cause mortality [Up to a maximum of 5.6 years]

    Time to death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Site SE46001 Uppsala Sweden SE-75185

Sponsors and Collaborators

  • Astellas Pharma Europe Ltd.

Investigators

  • Study Director: Central Contact, Astellas Pharma Europe Ltd.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Astellas Pharma Europe Ltd.
ClinicalTrials.gov Identifier:
NCT04042350
Other Study ID Numbers:
  • 1517-MA-3256
First Posted:
Aug 1, 2019
Last Update Posted:
Dec 9, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Astellas Pharma Europe Ltd.
AURORA
Cardiovascular Events
Chronic Kidney Disease
Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic

Study Results

No Results Posted as of Dec 9, 2020