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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2773}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-29', 'studyFirstSubmitDate': '2019-07-31', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first major adverse cardiovascular event (MACE)', 'timeFrame': 'Up to a maximum of 5.6 years', 'description': 'A MACE is defined as a non-fatal myocardial infarction (MI), non-fatal stroke, and CV mortality.'}], 'secondaryOutcomes': [{'measure': 'Time to a composite of any CV events', 'timeFrame': 'Up to a maximum of 5.6 years', 'description': 'CV events include non-fatal MI, unstable angina, coronary revascularization therapy, new onset heart failure, non-fatal stroke or all-cause mortality.'}, {'measure': 'Time to CV event: MI', 'timeFrame': 'Up to a maximum of 5.6 years', 'description': 'Time to individual CV event.'}, {'measure': 'Time to CV event: stroke (ischemic or hemorrhagic)', 'timeFrame': 'Up to a maximum of 5.6 years', 'description': 'Time to individual CV event.'}, {'measure': 'Time to CV event: unstable angina', 'timeFrame': 'Up to a maximum of 5.6 years', 'description': 'Time to individual CV event.'}, {'measure': 'Time to CV event: coronary revascularization therapy', 'timeFrame': 'Up to a maximum of 5.6 years', 'description': 'Time to individual CV event.'}, {'measure': 'Time to CV event: new onset heart failure', 'timeFrame': 'Up to a maximum of 5.6 years', 'description': 'Time to individual CV event.'}, {'measure': 'Time to CV mortality', 'timeFrame': 'Up to a maximum of 5.6 years', 'description': 'Time to death caused by a CV event.'}, {'measure': 'Time to all-cause mortality', 'timeFrame': 'Up to a maximum of 5.6 years', 'description': 'Time to death from any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AURORA', 'Cardiovascular Events', 'Chronic Kidney Disease'], 'conditions': ['Chronic Kidney Disease (CKD)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/hcp/study.aspx?ID=377', 'label': 'Link to results on the Astellas Clinical Study Results website.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe study will also establish a cardiovascular (CV) risk equation appropriate for this dialysis population.', 'detailedDescription': '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.\n\nAURORA 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.\n\nThe clinical study data is held by AstraZeneca AB, Sweden.\n\nNo formal sample size calculation was performed. The sample size is based on the available data from the AURORA study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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).\n\nExclusion Criteria:\n\n* 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.\n* 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.'}, 'identificationModule': {'nctId': 'NCT04042350', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '1517-MA-3256'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CKD patients on dialysis', 'description': 'Data will be analyzed from CKD patients on dialysis that participated in the AURORA study.', 'interventionNames': ['Other: Non-interventional']}], 'interventions': [{'name': 'Non-interventional', 'type': 'OTHER', 'description': 'Exploring clinical risk factors associated with the risk for cardiovascular events and mortality, rather than to evaluate specific drugs.', 'armGroupLabels': ['CKD patients on dialysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Site SE46001', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Central Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Europe Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "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/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Europe Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}