Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-02-27 @ 12:47 AM
Study NCT ID:
NCT02338128
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2015-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2015-01-09', 'studyFirstSubmitQcDate': '2015-01-13', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiovascular events (heart failure, myocardial infarction, unstable angina which need hospitalization，heart surgery, or death caused by cardiovascular disease.)', 'timeFrame': '1 year', 'description': 'heart failure, myocardial infarction, unstable angina which need hospitalization，heart surgery, or death caused by cardiovascular disease.'}], 'secondaryOutcomes': [{'measure': 'Serum uric acid', 'timeFrame': '1st month, 2nd month, 3rd month, 6th month, 9th month, 12th month', 'description': 'blood test for serum uric acid'}, {'measure': 'cardiovascular function (Heart construction and cardiac ejection fraction determined by echocardiography; blood test: cardiac markers including troponin,myoglobin and creatinine kinase, MB isoenzyme (CK-MB), brain natriuretic peptide)', 'timeFrame': '6 months', 'description': 'Heart construction and cardiac ejection fraction determined by echocardiography; blood test: cardiac markers including troponin,myoglobin and creatinine kinase, MB isoenzyme (CK-MB), brain natriuretic peptide.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['peritoneal dialysis', 'hyperuricemia', 'cardiovascular', 'Febuxostat'], 'conditions': ['Disorders Associated With Peritoneal Dialysis', 'Hyperuricemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Febuxostat could protect cardiovascular function of peritoneal dialysis patients by lowering serum uric acid.', 'detailedDescription': 'Patients with more than 3-month-history of peritoneal dialysis and hyperuricemia. Use Febuxostat to control their serum uric acid for 1 year. To observe the cardiovascular events of patients, and compare and evaluate the changes of heart function, heart construction, serum cardiac markers and brain natriuretic peptide (BNP) levels before and after Febuxostat treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Peritoneal dialysis patients with hyperuricemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Peritoneal dialysis for more than 3 months with hyperuricemia.\n\nExclusion Criteria:\n\n1. Acute hepatopathy or liver dysfunction (Aspartate transaminase and/or alanine aminotransferase exceed 2 times of normal range)\n2. Heart failure (stage IV, NYHA), unstable angina, acute stroke\n3. Severe lung disease or cancer\n4. unable to sign the informed consent form or disagree following-up.'}, 'identificationModule': {'nctId': 'NCT02338128', 'briefTitle': 'The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'The Cardiovascular Protective Effects of Febuxostat in Peritoneal Dialysis Patients: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'FPD2015'}}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': "Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Ling Wang, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Department of Nephrology & Rheumatology, Shanghai Tenth People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of department of Nephrology & Rheumatology', 'investigatorFullName': 'Ai Peng', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}