Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-01-12 @ 12:41 AM
Study NCT ID:
NCT01515605
Status:
RECRUITING
Last Update Posted:
2023-03-28
First Post:
2012-01-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, urine, tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2033-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-25', 'studyFirstSubmitDate': '2012-01-18', 'studyFirstSubmitQcDate': '2012-01-23', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2033-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cellular transcripts', 'timeFrame': 'Day1', 'description': 'Transcripts and protein'}], 'secondaryOutcomes': [{'measure': 'Cellular transcripts', 'timeFrame': 'Day8', 'description': 'Transcripts and protein'}, {'measure': 'Cellular transcripts', 'timeFrame': 'Day15', 'description': 'Transcripts and protein'}, {'measure': 'Cellular transcripts', 'timeFrame': 'Day22', 'description': 'Transcripts and protein'}, {'measure': 'Cellular transcripts', 'timeFrame': 'Day29', 'description': 'Transcripts and protein'}, {'measure': 'Plasma proteome', 'timeFrame': 'Day1', 'description': 'Plasma Proteome'}, {'measure': 'Plasma proteome', 'timeFrame': 'Day8', 'description': 'Plasma proteome'}, {'measure': 'Plasma proteome', 'timeFrame': 'Day15', 'description': 'Plasma proteome'}, {'measure': 'Plasma proteome', 'timeFrame': 'Day22', 'description': 'Plasma proteome'}, {'measure': 'Plasma proteome', 'timeFrame': 'Day29', 'description': 'Plasma proteome'}, {'measure': 'Urine proteome', 'timeFrame': 'Day1', 'description': 'Urine proteome'}, {'measure': 'Urine proteome', 'timeFrame': 'Day8', 'description': 'Urine proteome'}, {'measure': 'Urine proteome', 'timeFrame': 'Day15', 'description': 'Urine proteome'}, {'measure': 'Urine proteome', 'timeFrame': 'Day22', 'description': 'Urine proteome'}, {'measure': 'Urine proteome', 'timeFrame': 'Day29', 'description': 'Urine proteome'}, {'measure': 'Association of kidney function, glomerular filtration rate, infections, therapy', 'timeFrame': 'Day29', 'description': 'Association of kidney function, glomerular filtration rate, infections, therapy'}, {'measure': 'Association of kidney function, glomerular filtration rate, infections, therapy', 'timeFrame': 'Month6', 'description': 'Association of kidney function, glomerular filtration rate, infections, therapy'}, {'measure': 'Association of kidney function, glomerular filtration rate, infections, therapy', 'timeFrame': 'Month12', 'description': 'Association of kidney function, glomerular filtration rate, infections, therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Transplantation Infection', 'Kidney Diseases']}, 'descriptionModule': {'briefSummary': "Molecular monitoring is conducted in blood cells, plasma samples, urine samples and/or tissue from patients after kidney transplantation. In the present study the investigators examine the hypothesis that noninvasive diagnostic molecular monitoring can improve the outcome after transplantation.\n\nRoutine clinical and laboratory data from serum and urine are evaluated at baseline and after 0-1-2-3-4-12-16-52 weeks and 1-2-3-4-5-6-7-8-9-10 years after kidney transplantation. Mononuclear cells were obtained from the blood and transcripts of several diagnostic genes (including GATA3 (Trans-acting T-cell-specific transcription factor3), GATA4 (Trans-acting T-cell-specific transcription factor4), GAPDH (Glyceraldehyde 3-phosphate dehydrogenase), TRPC3 (Transient receptor potential cononical type3), TRPC6 (Transient receptor potential cononical type6), granzyme B, perforin, FOXP3 (Forkhead box P3), ISG15 (Interferon-stimulated gene 15), Mx1 (Interferon-induced GTP-binding protein), MMP3 (Matrix metalloproteinase-3), MMP9 (Matrix metalloproteinase-9), long-non-coding RNA, and others) are quantified using standard quantitative RT-PCR (Reverse transcription polymerase chain reaction) techniques. Proteomic analysis were performed in plasma and urine samples. Polymorphisms of selected genes are analyzed using standard techniques. Data are analyzed by descriptive statistics. Differences between groups were analyzed using Mann-Whitney test or Kruskal-Wallis-test and Dunn's multiple comparison post-test, as appropriate. Associations between variables are analyzed using regression analyses. Contingency tables are analyzed using Fisher's exact test.", 'detailedDescription': 'Molecular monitoring is conducted in blood cells, plasma samples, urine samples and/or tissue from recipients after kidney transplantation and donors. In the present study the investigators examine the hypothesis that noninvasive diagnostic molecular monitoring can improve the outcome after transplantation.\n\nRoutine clinical and laboratory data from serum and urine are evaluated at baseline and after 0-1-2-3-4-12-16-52 weeks and 1-2-3-4-5-6-7-8-9-10 years, after kidney transplantation. Mononuclear cells were obtained from the blood and transcripts of several diagnostic genes (including GATA3 (Trans-acting T-cell-specific transcription factor3), GATA4 (Trans-acting T-cell-specific transcription factor4), GAPDH (Glyceraldehyde 3-phosphate dehydrogenase), TRPC3 (Transient receptor potential cononical type3), TRPC6 (Transient receptor potential cononical type6), granzyme B, perforin, FOXP3 (Forkhead box P3), ISG15 (Interferon-stimulated gene 15), Mx1 (Interferon-induced GTP-binding protein), MMP3 (Matrix metalloproteinase-3), MMP9 (Matrix metalloproteinase-9), long-non-coding RNA, and others) are quantified using standard quantitative RT-PCR (Reverse transcription polymerase chain reaction) techniques. Proteomic analysis were performed in plasma and urine samples. Polymorphisms of selected genes are analyzed using standard techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Kidney transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients after kidney transplantation, male, female, informed consent\n\nExclusion Criteria:\n\n* Deny of informed consent'}, 'identificationModule': {'nctId': 'NCT01515605', 'acronym': 'MoMoTxRes', 'briefTitle': 'Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Molecular Biological and Moleculargenetic Monitoring of Therapy After Kidney Transplantation', 'orgStudyIdInfo': {'id': 'MoMoTxRes'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients after kidney transplantation', 'description': 'Patients after kidney transplantation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'DK', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Martin Tepel, Dr', 'role': 'CONTACT', 'email': 'mtepel@health.sdu.dk', 'phone': '4565503755'}, {'name': 'Martin Tepel, Dr', 'role': 'CONTACT', 'email': 'martin.tepel@rsyd.dk', 'phone': '4565503755'}, {'name': 'Martin Tepel, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Martin Tepel, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Martin Tepel', 'investigatorAffiliation': 'Odense University Hospital'}}}}