Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-04 @ 9:56 PM
Study NCT ID:
NCT01982903
Status:
UNKNOWN
Last Update Posted:
2016-05-26
First Post:
2013-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study of Urinary Markers of Fibrosis in Kidney Transplants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, serum, urine, renal allograft tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-25', 'studyFirstSubmitDate': '2013-10-31', 'studyFirstSubmitQcDate': '2013-11-06', 'lastUpdatePostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Allograft interstitial fibrosis (scored according to revised Banff 1997 criteria) in consecutive protocol biopsies', 'timeFrame': '24 months post-transplantation'}], 'secondaryOutcomes': [{'measure': 'Graft function (eGFR, calculated with the Modification of Diet in Renal Disease formula)', 'timeFrame': '24 months post-transplantation'}, {'measure': 'Proteinuria (measured as g/g creatinine in a 24-hr urine collection)', 'timeFrame': '24 months post-transplantation'}, {'measure': 'Urinary CTGF concentration', 'timeFrame': '24 months post-transplantation'}, {'measure': 'Intra-graft expression of CTGF', 'timeFrame': '24 months post-transplantation'}, {'measure': 'Urinary markers of tubular injury and dysfunction', 'timeFrame': '24 months post-transplantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['kidney transplantation', 'connective tissue growth factor', 'fibrosis'], 'conditions': ['Kidney Failure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether urinary connective tissue growth factor (uCTGF) can predict the onset of fibrosis in transplanted kidneys.', 'detailedDescription': 'Since March 2004, and as part of routine clinical practice, protocol renal allograft biopsies are routinely performed at implantation and at 3, 12 and 24 months after transplantation, in all patients who receive a kidney transplant at the University Hospitals Leuven, unless there is a medical contra-indication or patient refusal to undergo this procedure. The biopsies are scheduled using a dedicated Microsoft Access database ("Biopsy Database"), that is maintained on the central servers of the University Hospitals Leuven. Patients who have an unexplained change in renal allograft function, undergo additional clinically indicated indication biopsies. These biopsies are also recorded in the aforementioned Microsoft Access Database.\n\nAll clinical data, including pretransplant donor and recipient characteristics, and post-transplant follow-up data are directly stored and maintained in a prospectively collected electronic database (CCL database until 06/2012, transferred to the central KWS database in 2012). This electronic database is the only existing clinical database for these patients, and contains all clinical patient charts. No written records are collected.\n\nAll renal allograft biopsies will be scored by a single renal pathologist according to the most recent Banff classification, blinded for the clinical parameters and timing of the biopsy. These rescoring data are directly entered in the dedicated Microsoft Access database ("Biopsy Database").'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult recipients of a primary or secondary cadaveric or living donor single renal allograft at the University Hospitals Leuven.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who receive a primary or secondary single cadaveric or living donor renal allograft.\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients receiving a combined renal allograft.'}, 'identificationModule': {'nctId': 'NCT01982903', 'briefTitle': 'Prospective Study of Urinary Markers of Fibrosis in Kidney Transplants', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Prospective Study of Urinary Connective Tissue Growth Factor and Related Pro-fibrotic Mediators as Potential Early Biomarkers of Progressive Renal Allograft Fibrosis in de Novo Kidney Recipients', 'orgStudyIdInfo': {'id': 's55992'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kidney transplant recipients', 'description': 'Adult recipients of a primary or secondary cadaveric or living donor single renal allograft at the University Hospitals Leuven between July 2014 and June 2016'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Thomas Vanhove, MD', 'role': 'CONTACT', 'email': 'thomas.vanhove@uzleuven.be', 'phone': '+32 27055733'}], 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Thomas Vanhove, MD', 'role': 'CONTACT', 'email': 'thomas.vanhove@uzleuven.be', 'phone': '+32 27055733'}, {'name': 'Dirk Kuypers, MD, PhD', 'role': 'CONTACT', 'email': 'dirk.kuypers@uzleuven.be', 'phone': '+32 16344595'}], 'overallOfficials': [{'name': 'Dirk Kuypers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laboratory of Nephrology, University Hospitals Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Thomas Vanhove', 'investigatorFullName': 'Dr Thomas Vanhove', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}