Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2025-12-29 @ 9:28 AM
Study NCT ID:
NCT04478968
Status:
UNKNOWN
Last Update Posted:
2020-07-21
First Post:
2020-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Approach to Vascular Access After Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2022-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life with EQ-5D-5L', 'timeFrame': 'Baseline visit up to 12 months', 'description': 'The survey results will be compared between the study and control groups to see if the presence of the arteriovenous fistula affects quality of life.'}, {'measure': 'Prognostic value of biomarkers (NT-proBNP, Il-6, sST2, galectin-3, GDF-15, MMP7, TIMP1)', 'timeFrame': 'Baseline visit and up to 12 months', 'description': 'The levels of biomarkers will be measured and the results will be compared between the study and control groups. A prognostic value of the biomarkers will be estimated.'}], 'secondaryOutcomes': [{'measure': 'Hospitalization-free survival', 'timeFrame': 'Up to 12 months from baseline visit', 'description': 'Hospital-free survival will be reported as the number of patients living 12 months after the initial visit without the need for hospitalization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Arteriovenous Fistula'], 'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'The aim of the project is to assess the effect of functioning AVF in renal transplant patients on fibrosis, inflammation and LVH indicators. Clinical and laboratory parameters will be compared in a group of 150 patients, 75 patients with a functioning fistula and 75 patients with inactive vascular access. We will assess the impact of functional AVF and the levels of biomarkers on the survival of patients and transplanted kidneys.', 'detailedDescription': 'Patients after kidney transplantation during a routine visit will be asked to participate to the study. In eligible a number of studies will be conducted:\n\n* detailed clinical examination\n* routine laboratory tests\n* lung ultrasound\n* muscle strength with a dynamometer\n* ultrasound assessment of upper limb vessels with assessment of fistula function (in the case of active fistula) and for the possibility of future vascular access\n* blood collection and protection (10-15 ml) for biomarkers\n* survey EQ-5D-5L and LVD-36\n* functional strength test.\n\nThe obtained clinical data and test results will be subject to statistical analysis after anonymization. The impact of individual parameters on long-term prognosis will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have had a kidney transplant belong to the group of patients at increased risk for cardiovascular disease.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\> 18 years old\n* kidney transplant\n* \\>12 months after transplantation\n* stable transplanted kidney function\n* signed informed consent\n\nExclusion Criteria:\n\n* GFR \\<15 ml / min\n* severe infection within 3 months of testing\n* increase in creatinine concentration\\> 0.5 mg / dl within 3 months before the test\n* active cancer\n* signs of severe heart failure (NYHA IV)'}, 'identificationModule': {'nctId': 'NCT04478968', 'acronym': 'AVART', 'briefTitle': 'Approach to Vascular Access After Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Wroclaw Medical University'}, 'officialTitle': 'The Levels of Fibrosis Biomarkers in Patients After Renal Transplantation in Relation to Arteriovenous Fistula Function', 'orgStudyIdInfo': {'id': 'MINI.C160.20.001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Active AVF', 'description': 'Patients after kidney transplantation with functioning AVF', 'interventionNames': ['Other: presence of AVF']}, {'label': 'No AVF', 'description': 'Patients after kidney transplantation without AVF (thrombosed AVF, history of HD with catheter, history of PD, preemptive transplantation)'}], 'interventions': [{'name': 'presence of AVF', 'type': 'OTHER', 'description': 'Functioning AVF may have cardiotoxic potential', 'armGroupLabels': ['Active AVF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55-556', 'city': 'Wroclaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Krzysztof Letachowicz, MD, PhD', 'role': 'CONTACT', 'email': 'krzysztof.letachowiocz@umed.wroc.pl', 'phone': '+48717332546'}], 'facility': 'Department of Nephrology and Transplantation Medicine', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'centralContacts': [{'name': 'Krzysztof Letachowicz, MD, PhD', 'role': 'CONTACT', 'email': 'krzysztof.letachowicz@umed.wroc.pl', 'phone': '+48717332546'}], 'overallOfficials': [{'name': 'Krzysztof Letachowicz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wroclaw Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wroclaw Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}