Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT05140018
Status:
RECRUITING
Last Update Posted:
2023-05-11
First Post:
2021-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence, Course and Outcome of ABMR in Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016030', 'term': 'Kidney Transplantation'}, {'id': 'D007165', 'term': 'Immunosuppression Therapy'}, {'id': 'D009392', 'term': 'Nephrectomy'}], 'ancestors': [{'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016377', 'term': 'Organ Transplantation'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral Blood Mononuclear Cells (PBMCs) Kidney biopsy material (in case when kidney biopsy is performed in the follow-up) Iliac lymph nodes from 15 selected kidney transplant recipients'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-09', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Antibody-Mediated Rejection (ABMR)', 'timeFrame': 'within 12 months after transplantation', 'description': 'Incidence of Antibody-Mediated Rejection (ABMR) as histopathological diagnosis'}, {'measure': 'Incidence of mixed Antibody-Mediated Rejection / T-Cell Mediated Rejection (ABMR/TCMR)', 'timeFrame': 'within 12 months after transplantation', 'description': 'Incidence of mixed Antibody-Mediated Rejection / T-Cell Mediated Rejection as histopathological diagnosis(ABMR/TCMR) as histopathological diagnosis'}, {'measure': 'Kidney transplant function', 'timeFrame': 'at 12 months after transplantation', 'description': 'as measured by eGFR and proteinuria'}], 'secondaryOutcomes': [{'measure': 'Development of Human-Leukocyte Antigen (HLA) antibodies', 'timeFrame': 'At 3 and 12 months after transplantation', 'description': 'As measured by Luminex assay at 3 and 12 months'}, {'measure': 'Development of non-HLA antibodies', 'timeFrame': 'At 3 and 12 months after transplantation', 'description': 'Development of non-HLA antibodies as measured by a cell-based endothelial assay'}, {'measure': 'Kidney transplant survival', 'timeFrame': 'At 12 months after transplantation', 'description': 'Kidney transplant survival in patients experiencing ABMR versus those not experiencing ABMR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Antibody-mediated Rejection', 'Kidney Transplantation', 'Immunosuppression']}, 'descriptionModule': {'briefSummary': 'Rationale: Despite improved patient and graft survival in renal transplant recipients, still 20% of the patients reaches end-stage renal disease within 5 years after transplantation. Antibody-mediated rejection (ABMR) is one of the major causes of early graft loss and perhaps even more important of late deterioration of graft function\n\nObjective: Evaluate the occurrence of antibody mediated rejection (ABMR) and mixed ABMR and cellular/ T-cell mediated rejection (TCMR), in patients treated with the currently prevailing immunosuppressive regimens, and relate them to outcome (graft survival, function, proteinuria, histology)\n\nStudy design: Clinical cohort study.\n\nStudy population: patients of \\>18 years old, about to receive a post mortal of living donor renal transplant with an immunological high risk for ABMR.\n\nMain study parameters/endpoints: main study endpoints are the occurrence of ABMR, mixed ABMR/TCMR and renal function after 1 year of follow-up.\n\nThe main study parameter will be mapping the immune system, including B-cells, (non-)HLA antibodies, interaction between B-cells and T follicular helper cells, and complete immune profiling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with eind-stage renale disease (ESRD) who are about to receive a kidney transplant from a living or deceased donor, with an elevated immunological risk (higher risk for (antibody-mediated) rejection).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kidney transplant recipients ≥18 years old\n* About to receive a post mortal or living donor renal transplant\n* written informed consent (is able to read of understand in Dutch)\n* Immunological high risk for rejection\n\n 1. Luminex positive DSAs ; or\n 2. Retransplantation with repeated mismatch ; or\n 3. Husband to wife donation (after fathering children); or\n 4. Offspring to mother donation\n\nExclusion Criteria:\n\n* No immunological high risk'}, 'identificationModule': {'nctId': 'NCT05140018', 'acronym': 'PROCARE2', 'briefTitle': 'Incidence, Course and Outcome of ABMR in Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'Incidence, Course and Outcome of Cellular and Antibody-mediated Rejection in Immunological High-risk Kidney Transplantation, a Prospective Cohort PROCARE2 Study', 'orgStudyIdInfo': {'id': 'PROCARE2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Kidney Transplant Recipients with an immunological high risk for ABMR', 'description': '* Kidney transplant recipients ≥18 years old\n* About to receive a post mortal or living donor renal transplant\n* Immunological high risk for rejection\n\n 1. Luminex positive DSAs ; or\n 2. Retransplantation with repeated mismatch ; or\n 3. Husband to wife donation (after fathering children); or\n 4. Offspring to mother donation', 'interventionNames': ['Procedure: Kidney Transplantation', 'Combination Product: Immunosuppression']}, {'label': 'Living Kidney Donors', 'description': 'Participants who are about to donate their kidney to a Recipient with a high immunological risk (as described above)', 'interventionNames': ['Procedure: Nephrectomy (kidney donation)']}], 'interventions': [{'name': 'Kidney Transplantation', 'type': 'PROCEDURE', 'description': 'All participants will receive a kidney transplantation from a living donor or deceased donor', 'armGroupLabels': ['Kidney Transplant Recipients with an immunological high risk for ABMR']}, {'name': 'Immunosuppression', 'type': 'COMBINATION_PRODUCT', 'description': 'All participants will receive immunosuppresive drugs to prevent rejection of de kidney transplant graft.', 'armGroupLabels': ['Kidney Transplant Recipients with an immunological high risk for ABMR']}, {'name': 'Nephrectomy (kidney donation)', 'type': 'PROCEDURE', 'description': 'All kidney donors will receive a nephrectomy for kidney donation', 'armGroupLabels': ['Living Kidney Donors']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Frederike Bemelman, MD, PhD', 'role': 'CONTACT'}, {'name': 'Frederike Bemelman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jan-Stephan Sanders, MD, PhD', 'role': 'CONTACT', 'email': 'j.sanders@umcg.nl', 'phone': '+31503616161'}, {'name': 'Jan-Stephan Sanders, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Leiden', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Aiko de Vries, MD, PhD', 'role': 'CONTACT'}, {'name': 'Aiko de Vries, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marije Baas, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Radboud University Hospital', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Dennis Hesselink, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Arjan Van Zuilen, MD, PhD', 'role': 'CONTACT'}], 'facility': 'UMCU', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'centralContacts': [{'name': 'Jan-Stephan Sanders, MD PhD', 'role': 'CONTACT', 'email': 'j.sanders@umcg.nl', 'phone': '+31503612955'}, {'name': 'Joost van den Born, MD PhD', 'role': 'CONTACT', 'email': 'j.c.van.den.born@umcg.nl', 'phone': '+31503612955'}], 'overallOfficials': [{'name': 'Hendrikus Otten, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'UMC Utrecht'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Kidney Foundation', 'class': 'OTHER'}, {'name': 'UMC Utrecht', 'class': 'OTHER'}, {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, {'name': 'Radboud University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'J.S.F. Sanders', 'investigatorAffiliation': 'University Medical Center Groningen'}}}}