Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-27 @ 11:37 AM
Study NCT ID:
NCT04226859
Status:
UNKNOWN
Last Update Posted:
2020-01-18
First Post:
2020-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trajectories of Glomerular Filtration Rate and Progression to End Stage Renal Disease After Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2000-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-13', 'studyFirstSubmitDate': '2020-01-09', 'studyFirstSubmitQcDate': '2020-01-09', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'eGFR trajectories', 'timeFrame': 'Up to 10 years after kidney transplantation', 'description': 'eGFR trajectories probabilities, calculated from a prediction system (based on clinical, histological, immunological, and functional factors) assessed at 1-year post transplantation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney Transplantation', 'Graft Survival', 'Glomerular Filtration Rate', 'Trajectories'], 'conditions': ['Kidney Transplant Failure', 'Kidney Function Issue']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.paristransplantgroup.org', 'label': 'Paris Transplant Group Website'}]}, 'descriptionModule': {'briefSummary': 'The gold standard for characterizing chronic kidney disease (CKD) is the glomerular filtration rate (GFR), which is commonly estimated in both native and transplanted kidneys for patient monitoring and therapeutic management and ultimately guides decision-making about whether a patient needs renal replacement therapy. In particular, the National Kidney Foundation has defined CKD stages according to estimated GFR (eGFR) values and in several studies, the eGFR slope or change has been found to be strongly associated with end stage renal disease (ESRD).\n\nHowever, little is known about the heterogeneity of eGFR evolution in time - i.e. eGFR trajectories - and the related progression to ESRD and death. To date, no studies have investigated eGFR trajectories in diversified cohorts and populations worldwide, although this approach could provide a better understanding of CKD evolution and hence improve risk stratification. In addition, determinants of eGFR trajectories remain poorly described.\n\nAn unsupervised approach could allow examining eGFR trajectories over time and could lead to the identification of patient groups according to the probability of the progression of their kidney disease.\n\nTherefore, this study aims:\n\n1. To identify the long-term eGFR trajectories after kidney transplantation using latent class mixed models;\n2. To identify the clinical, immunological, histological and functional determinants of the eGFR trajectories using multinomial regressions;\n3. To investigate the associations of the eGFR trajectories with the progression to ESRD and death.\n\nBased on the results, the investigators will provide an easily accessible tool to calculate personalized probabilities of belonging to eGFR trajectories after kidney transplantation, by using datasets from prospective cohorts and post hoc analysis of randomized control trial datasets.', 'detailedDescription': 'Background\n\nChronic kidney disease (CKD) now affects 850 million individuals worldwide, exceeding the global prevalence of diabetes, cancer and HIV/AIDS. In addition, end-stage renal disease affects 7.4 million individuals and mortality rate for individuals burdened by kidney disease is now estimated at 5 to 10 million individuals each year. Therefore, developing better diagnostic and treatment approaches for the kidney disease epidemic is a global priority, as leading professional societies and health agencies have emphasized (the US Food \\& Drug Administration, the National Kidney Foundation, the European Medicines Agency, the European Society of Organ Transplantation, the American Society for Transplantation and the American Society of Transplant Surgeons).\n\nHowever, current approaches for investigating the relationship between eGFR course and outcomes such as ESRD and mortality have been limited by registries with an overall lack on granular data, including infrequent eGFR measurements for a single patient and convenience clinical samples. An unsupervised longitudinal approach to determine patient eGFR evolution may bring an original perspective to the traditional clinical interpretation of kidney function based on limited eGFR measurements, short-term follow-up, and standard statistical approach.\n\nMain Outcome(s) and Measure(s)\n\n* eGFR trajectories\n* Determinants of eGFR trajectories\n* Associations of eGFR trajectories with ESRD and death\n* Prediction system that will provide the personalized probabilities of belonging to eGFR trajectories'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Kidney recipients aged over 18 and of all sexes recruited from 2000 in European and North American centers, who have eGFR repeated measurements, data from protocol and for cause biopsies, as well as immunological, clinical, functional parameters and survival data for allograft and patient survival assessment. Additional kidney recipients from RCTs with longitudinal data including baseline and follow-up clinical, functional, immunological and histological data.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kidney recipients transplanted after 2000\n* Kidney recipients over 18 years of age\n* Kidney recipients with at least two eGFR measurements after transplantation\n\nExclusion Criteria:\n\n* Combined transplantation'}, 'identificationModule': {'nctId': 'NCT04226859', 'acronym': 'TRAJAKT', 'briefTitle': 'Trajectories of Glomerular Filtration Rate and Progression to End Stage Renal Disease After Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Paris Translational Research Center for Organ Transplantation'}, 'officialTitle': 'Multicenter International Observational Study to Identify eGFR Trajectories and Their Determinants, and to Build a Multidimensional Prediction System to Predict the Probabilities of Belonging to eGFR Trajectories', 'orgStudyIdInfo': {'id': 'TRAJAKT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Kidney recipients aged over 18 and of all sexes recruited from 2000 in European and North American centers, who have eGFR follow-up and data from protocol and for cause biopsies available for allograft survival assessment; Randomized controlled trials conducted over the past 20 years with available data on protocol biopsy within the first year and follow up clinical, biological and histological data.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'status': 'ENROLLING_BY_INVITATION', 'country': 'United States', 'facility': 'Department of Medicine, Division of Nephrology, Comprehensive Transplant Center, Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'ENROLLING_BY_INVITATION', 'country': 'United States', 'facility': 'Department of Surgery, Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'ENROLLING_BY_INVITATION', 'country': 'United States', 'facility': 'William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10467', 'city': 'New York', 'state': 'New York', 'status': 'ENROLLING_BY_INVITATION', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine, Renal Division Montefiore Medical Center, Kidney Transplantation Program', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '980663', 'city': 'Richmond', 'state': 'Virginia', 'status': 'ENROLLING_BY_INVITATION', 'country': 'United States', 'facility': 'Virginia Commonwealth University School of Medicine', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '3000', 'city': 'Leuven', 'status': 'ENROLLING_BY_INVITATION', 'country': 'Belgium', 'facility': 'Department of Nephrology and Renal Transplantation, University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '10000', 'city': 'Zagreb', 'status': 'ENROLLING_BY_INVITATION', 'country': 'Croatia', 'facility': 'Department of Nephrology, Arterial Hypertension, Dialysis and Transplantation, University Hospital Centre Zagreb, School od Medicine University of Zagreb', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '34295', 'city': 'Montpellier', 'status': 'ENROLLING_BY_INVITATION', 'country': 'France', 'facility': 'Department of Nephrology, Centre Hospitalier Universitaire de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54035', 'city': 'Nancy', 'status': 'ENROLLING_BY_INVITATION', 'country': 'France', 'facility': 'Nephrology Dialysis Transplantation Department, University of Lorraine, Centre Hospitalier Universitaire de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '44093', 'city': 'Nantes', 'status': 'ENROLLING_BY_INVITATION', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Carmen Lefaucheur, MD', 'role': 'CONTACT'}], 'facility': 'Kidney Transplant Department, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandre Loupy, Professor', 'role': 'CONTACT', 'email': 'alexandre.loupy@inserm.fr', 'phone': '+33612491082'}], 'facility': 'Kidney Transplant Department, Necker Hospital, Assistance Publique - Hôpitaux de Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92150', 'city': 'Suresnes', 'status': 'ENROLLING_BY_INVITATION', 'country': 'France', 'facility': 'Department of Transplantation, Nephrology and Clinical Immunology, Hôpital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '31059', 'city': 'Toulouse', 'status': 'ENROLLING_BY_INVITATION', 'country': 'France', 'facility': 'Department of Nephrology and Organ Transplantation, Centre Hospitalier Universitaire Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'status': 'ENROLLING_BY_INVITATION', 'country': 'France', 'facility': 'Bretonneau Hospital, Nephrology and Immunology Department', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Alexandre Loupy, Professor', 'role': 'CONTACT', 'email': 'alexandre.loupy@inserm.fr'}, {'name': 'Marc Raynaud', 'role': 'CONTACT', 'email': 'mrayna06@gmail.com', 'phone': '+33613493009'}], 'overallOfficials': [{'name': 'Alexandre Loupy, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Paris Translational Research Center for Organ Transplantation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paris Translational Research Center for Organ Transplantation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}