Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-29 @ 5:12 AM
Study NCT ID:
NCT06047106
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-09-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, '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', 'interventionModelDescription': 'Monocentric, Prospective, Non-randomized, Exploratory Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-27', 'studyFirstSubmitDate': '2023-09-14', 'studyFirstSubmitQcDate': '2023-09-20', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apparent diffusion coefficient (ADC) coefficient values measured in diffusion-weighted MRI sequence', 'timeFrame': 'Baseline before transplantation, one month and 12 months after kidney transplantation'}], 'secondaryOutcomes': [{'measure': 'In recipients, R2* values measured by BOLD MRI', 'timeFrame': 'Baseline before transplantation, one month and 12 months after kidney transplantation'}, {'measure': 'In recipients, T2 Values measured by T2 mapping MRI', 'timeFrame': 'Baseline before transplantation, one month and 12 months after kidney transplantation'}, {'measure': 'In recipients, T1 Values measured by T1 mapping MRI', 'timeFrame': 'Baseline before transplantation, one month and 12 months after kidney transplantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Living Donor Donation', 'multiparametric MRI', 'ischemia reperfusion injury', 'kidney graft'], 'conditions': ['Renal Insufficiency, Chronic']}, 'descriptionModule': {'briefSummary': "The selection of kidneys from living donors is based on strict glomerular filtration rate (GFR) values, in the setting of the increasing proportion of older donors. The 2017 KDIGO recommendations consider that approving kidney donation for a donor with a GFR between 60 and 89 mL/min/1.73 m² should be individually discussed, possibly using a calculator. A GFR \\< 60 mL/min/1.73 m² should contraindicate donation without considering the donor's age.\n\nGFR physiologically decreases with age, so older donors frequently have a GFR below 90 ml/min/1.73 m². However, the proportion of older donors continues to rise.\n\nKidney grafts from older living donors maintain better renal function than those from deceased donors, aiming to counteract the organ shortage.\n\nKidneys possess functional reserves, allowing an increase in GFR during stimulations and adaptation to reduced functional nephron count (as after nephrectomy). Assessing this adaptive capacity clinically is challenging. It might be dependent on vascularization and/or absence of fibrosis, but these parameters are poorly understood due to a lack of current in vivo exploration methods.\n\nThe development of functional renal MRI enables the evaluation of these parameters, allowing measurements on separate, regional, non-invasive, quantitative kidney segments coupled with morphological studies. BOLD-MRI can measure regional oxygen content, thus accessing more precise medullary data. The DWI sequence can estimate renal microstructure and study interstitial fibrosis.\n\nTherefore, evaluating renal performance (by measuring GFR, renal perfusion, fibrosis, inflammation, and oxygen content) in donors, and studying the evolution of these parameters in recipients and donors, could optimize donor selection.\n\nHence, the aim of our study is to 1) investigate the evolution of renal functional parameters in the transplanted kidney up to 1 year post-transplant, and 2) study the evolution of these same parameters in the contralateral kidney of the donor."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor recipients:\n\n* Patients with end-stage chronic kidney disease awaiting kidney transplant from a living donor.\n* Adult patient\n* Consent signed\n* effective contraceptive method for women\n* Patient affiliated to a social security or beneficiaries of a similar scheme\n\nFor donors:\n\n* Individuals eligible for living kidney donation with GFR \\> 60 mL/min/1.73 m².\n* Adult patient\n* Consent signed\n* effective contraceptive method for women\n* Patient affiliated to a social security or beneficiaries of a similar scheme\n\nExclusion Criteria:\n\nFor the two groups :\n\n* MRI contraindications (claustrophobia, pacemaker, cardioverter defibrillators implantable, mechanical heart valve non MRI-compatible)\n* Weight\\> 130 kg\n* Pregnant, parturient or breastfeeding\n* Persons deprived of their liberty by a judicial or administrative decision,\n* Adults subject to a legal protection measure (safeguard measure, guardianship, curators)\n* subject participating in another research including an exclusion period still in progress at inclusion\n\nFor recipients :\n\n\\- Contraindication to renal graft biopsy (ongoing or uninterrupted anticoagulant or antiplatelet treatment, thrombocytopenia \\<100 x 10\\^9/L, anemia \\<7 g/dL).'}, 'identificationModule': {'nctId': 'NCT06047106', 'acronym': 'DOVIMIR', 'briefTitle': 'Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'DOVIMIR : Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation', 'orgStudyIdInfo': {'id': '69HCL23_0324'}, 'secondaryIdInfos': [{'id': '2023-A01402-43', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Living kidney donor', 'description': 'Patient eligible for living kidney donation with eGFR \\> 60 ml/min/1.73m²', 'interventionNames': ['Radiation: multiparametric MRI', 'Biological: blood samples', 'Biological: urine specimens']}, {'type': 'EXPERIMENTAL', 'label': 'Recipient of kidney transplant from living donor', 'description': 'Patient with end-stage chronic kidney failure awaiting kidney transplant from living donor', 'interventionNames': ['Radiation: multiparametric MRI', 'Procedure: kidney graft biopsy', 'Biological: blood samples', 'Biological: urine specimens']}], 'interventions': [{'name': 'multiparametric MRI', 'type': 'RADIATION', 'description': 'For the living donor, multiparametric MRI will be added in the day hospital: at the pre-transplant assessment and at the 12-month post-transplant assessment.\n\nFor the recipient: multiparametric MRI will be added in the day hospital at the time of the systematic assessment at 1 month post-transplant, and will be added in the day hospital at the time of the 12-month post-transplant assessment.', 'armGroupLabels': ['Living kidney donor', 'Recipient of kidney transplant from living donor']}, {'name': 'kidney graft biopsy', 'type': 'PROCEDURE', 'description': 'Biopsy of the graft itself prior to transplantation in the recipient.', 'armGroupLabels': ['Recipient of kidney transplant from living donor']}, {'name': 'blood samples', 'type': 'BIOLOGICAL', 'description': 'For donors who are not selected to donate their kidney, a total of 2 mL of blood will be collected at inclusion.\n\nFor donors eligible to donate, a total of 4 mL of blood will be collected (at inclusion and at 12 months post-transplant).\n\nFor recipients, a total of 26 mL of blood will be collected (pre-transplant, 1 month and 12 months post-transplant).', 'armGroupLabels': ['Living kidney donor', 'Recipient of kidney transplant from living donor']}, {'name': 'urine specimens', 'type': 'BIOLOGICAL', 'description': 'For donors who are not selected to donate their kidney, a total of 15 mL of urine will be collected at inclusion.\n\nFor donors eligible to donate, a total of 50 mL of urine will be collected (at inclusion and at 12 months post-transplant).\n\nFor recipients, a total of 65 mL of urine will be collected (pre-transplant, 1 month and 12 months post-transplant).', 'armGroupLabels': ['Living kidney donor', 'Recipient of kidney transplant from living donor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'SANDRINE PU-PH LEMOINE', 'role': 'CONTACT', 'email': 'sandrine.lemoine01@chu-lyon.fr', 'phone': '0687947771', 'phoneExt': '+33'}], 'facility': 'Hôpital Edouard Herriot, Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Sandrine LEMOINE, PU-PH', 'role': 'CONTACT', 'email': 'sandrine.lemoine01@chu-lyon.fr', 'phone': '04 72 11 02 44'}, {'name': 'Marine GIRERD', 'role': 'CONTACT', 'email': 'marine.girerd@chu-lyon.fr', 'phone': '04 72 11 06 20'}], 'overallOfficials': [{'name': 'Sandrine LEMOINE, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service de néphrologie à l'Hôpital Edouard Herriot"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}