Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 12:02 PM
Study NCT ID:
NCT06976008
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CMV-associated Immunomodulation in Renal Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of CMV infection on the heterologous innate immune response in kidney transplant patients', 'timeFrame': '12 months', 'description': 'Comparison of the amount of cytokine production after stimulation of innate immune cells with whole microorganisms (E. Coli, Candida, Aspergillus, influenza virus) in solid organ transplant recipients with and without CMV over time.'}], 'secondaryOutcomes': [{'measure': 'Impact of CMV infection on the heterologous adaptive immune response in kidney transplant patients', 'timeFrame': '12 months', 'description': 'Comparison of the amount of cytokine production after stimulation of adaptative immune cells with a T-cell superantigen and CMV proteins in solid organ transplant recipients with and without CMV over time.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney transplant', 'Solid organ transplantation', 'Cytomegalovirus infection', 'Immunomodulatory effect of cytomegalovirus infection', 'Heterologous infection'], 'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'Cytomegalovirus (CMV) infection has been associated with an increased risk of bacterial, fungal and viral infections in solid organ transplant recipients. The purpose of this study to evaluate if the occurrence of CMV viremia modify the ability to develop optimal immune responses against other pathogens in kidney transplant recipients (heterologous immunity). The objective of this project is to identify the immune pathways affected by CMV in the context of immunosuppression associated with kidney transplantation.', 'detailedDescription': 'Cytomegalovirus (CMV) infection remains one of the most frequent and problematic complications of solid organ transplantation. Several epidemiological studies have shown an association between CMV infection and the occurrence of severe bacterial or fungal infections. However, the mechanisms by which CMV increases the risk of heterologous infection are still poorly understood. Several data support a direct or indirect immunomodulatory effect of CMV. Indeed, in healthy subjects, CMV seropositivity has a strong phenotypic and functional impact on adaptive immunity while in solid organ transplant patients, a decrease in the innate response to various antigenic stimuli has been observed during CMV viremia. The hypothesis of the study is that the occurrence of CMV viremia reduces the ability to develop optimal immune responses against other targeted pathogens in kidney transplant recipients (heterologous immunity). The objective of this project is to identify the immune pathways affected by CMV in the context of immunosuppression associated with kidney transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. st cohort :\n\n * Age \\> 18 years\n * patients with end-stage renal failure programmed for kidney transplantation with a live donor\n2. nd cohort :\n\n * Age \\> 18 years\n * kidney transplant recipient with CMV viremia\n\nExclusion Criteria:\n\n\\- Patients under guardianship, curatorship, legal protection.\n\nFor patients with end-stage renal failure scheduled to receive a kidney transplant from a living donor :\n\n* Patients with an active viral (other than CMV), bacterial or fungal infection at the time of inclusion\n* patients receiving a desensitization protocol (ABO or anti-HLA)'}, 'identificationModule': {'nctId': 'NCT06976008', 'acronym': 'IMMCMV', 'briefTitle': 'CMV-associated Immunomodulation in Renal Transplant Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'CMV-associated Immunomodulation in Renal Transplant Patients', 'orgStudyIdInfo': {'id': 'APHP240837'}, 'secondaryIdInfos': [{'id': 'ID-RCB Number : 2024-A01039-38', 'type': 'OTHER', 'domain': 'France : Ministry of Health'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kidney transplant recipients followed since the day of the transplantation', 'description': 'Kidney transplant recipients followed since the day of the transplantation', 'interventionNames': ['Other: blood sampling']}, {'type': 'EXPERIMENTAL', 'label': 'kidney transplant recipients with CMV viremia', 'description': 'kidney transplant recipients with CMV viremia', 'interventionNames': ['Other: blood sampling']}], 'interventions': [{'name': 'blood sampling', 'type': 'OTHER', 'description': 'Blood samples will be taken at different timepoints following CMV viremia to evaluate the impact of CMV viremia over time.', 'armGroupLabels': ['Kidney transplant recipients followed since the day of the transplantation', 'kidney transplant recipients with CMV viremia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'contacts': [{'name': 'Renaud Snanoudj, MD, PhD', 'role': 'CONTACT', 'email': 'renaud.snanoudj@aphp.fr', 'phone': '0145212721', 'phoneExt': '+33'}], 'facility': 'Hôpital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Eric Thervet, M.D., PhD', 'role': 'CONTACT', 'email': 'eric.thervet@aphp.fr', 'phone': '0156095700', 'phoneExt': '+33'}], 'facility': 'Hôpital européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Alexandra Serris, MD, PhD', 'role': 'CONTACT', 'email': 'alexandra.serris@aphp.fr', 'phone': '+33144381799'}, {'name': 'Serris', 'role': 'CONTACT'}, {'name': 'Fanny Lanternier, M.D., PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dany Anglicheau, M.D., PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julien Zuber, M.D., PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hôpital Necker-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Alexandra Serris, MD, PhD', 'role': 'CONTACT', 'email': 'alexandra.serris@aphp.fr', 'phone': '+33144381799'}, {'name': 'Serris', 'role': 'CONTACT'}], 'facility': 'Insitut Pasteur', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Alexandra Serris, MD, PhD', 'role': 'CONTACT', 'email': 'alexandra.serris@aphp.fr', 'phone': '0144 381799', 'phoneExt': '+33'}, {'name': 'Hélène Morel', 'role': 'CONTACT', 'email': 'helene.morel@aphp.fr', 'phone': '0171196346', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Alexandra Serris', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}