Chronic Kidney Disease (CKD)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
An observational study of Chronic Kidney Disease (CKD), run by Astellas Pharma Europe Ltd. at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Chronic Kidney Disease (CKD)
- What is being tested?
- Non-interventional
- How many people
- 2,773 participants
- Where
- 1 siteSweden
- Study dates
- 22 May 2019to 19 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read 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 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)
- Being tested
- Non-interventional
- Keywords
- AURORA, Cardiovascular Events, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
Exploring clinical risk factors associated with the risk for cardiovascular events and mortality, rather than to evaluate specific drugs.
| Study group | Role | What they receive |
|---|---|---|
| CKD patients on dialysis | Data will be analyzed from CKD patients on dialysis that participated in the AURORA study. Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to a maximum of 5.6 years
Secondary outcomes (8)
Time to a composite of any CV events
CV events include non-fatal MI, unstable angina, coronary revascularization therapy, new onset heart failure, non-fatal stroke or all-cause mortality.
Measured: Up to a maximum of 5.6 years
Time to CV event: MI
Time to individual CV event.
Measured: Up to a maximum of 5.6 years
Time to CV event: stroke (ischemic or hemorrhagic)
Time to individual CV event.
Measured: Up to a maximum of 5.6 years
Time to CV event: unstable angina
Time to individual CV event.
Measured: Up to a maximum of 5.6 years
Time to CV event: coronary revascularization therapy
Time to individual CV event.
Measured: Up to a maximum of 5.6 years
Time to CV event: new onset heart failure
Time to individual CV event.
Measured: Up to a maximum of 5.6 years
Time to CV mortality
Time to death caused by a CV event.
Measured: Up to a maximum of 5.6 years
Time to all-cause mortality
Time to death from any cause.
Measured: Up to a maximum of 5.6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start22 May 2019
- Primary completion19 Feb 2020
- Study completion19 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042350
- Sponsor's protocol ID
- 1517-MA-3256
- Status last verified
- Oct 2024
- First submitted
- 31 Jul 2019
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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/.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04042350
- Acronym / sponsor ID
- 1517-MA-3256
- Conditions
- Chronic Kidney Disease (CKD)
- Keywords
- AURORA, Cardiovascular Events, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,773 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 May 2019 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD patients on dialysis | – | Other: Non-interventionalData will be analyzed from CKD patients on dialysis that participated in the AURORA study. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalExploring clinical risk factors associated with the risk for cardiovascular events and mortality, rather than to evaluate specific drugs. | Other | CKD patients on dialysis |
Primary outcome
Time to first major adverse cardiovascular event (MACE)
Time frame: 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.
8 secondary outcomes
Time to a composite of any CV events
Time frame: Up to a maximum of 5.6 years
Time to CV event: MI
Time frame: Up to a maximum of 5.6 years
Time to CV event: stroke (ischemic or hemorrhagic)
Time frame: Up to a maximum of 5.6 years
Time to CV event: unstable angina
Time frame: Up to a maximum of 5.6 years
Time to CV event: coronary revascularization therapy
Time frame: Up to a maximum of 5.6 years
Time to CV event: new onset heart failure
Time frame: Up to a maximum of 5.6 years
Time to CV mortality
Time frame: Up to a maximum of 5.6 years
Time to all-cause mortality
Time frame: Up to a maximum of 5.6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Central Contact study director
Astellas Pharma Europe Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease (CKD), run by Astellas Pharma Europe Ltd. at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first major adverse cardiovascular event (MACE) (time frame: Up to a maximum of 5.6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.