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Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation. (DOVIMIR)

Primary Purpose

Renal Insufficiency, Chronic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
multiparametric MRI
kidney graft biopsy
blood samples
urine specimens
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Renal Insufficiency, Chronic focused on measuring Living Donor Donation, multiparametric MRI, ischemia reperfusion injury, kidney graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: For recipients: Patients with end-stage chronic kidney disease awaiting kidney transplant from a living donor. Adult patient Consent signed effective contraceptive method for women Patient affiliated to a social security or beneficiaries of a similar scheme For donors: Individuals eligible for living kidney donation with GFR > 60 mL/min/1.73 m². Adult patient Consent signed effective contraceptive method for women Patient affiliated to a social security or beneficiaries of a similar scheme Exclusion Criteria: For the two groups : MRI contraindications (claustrophobia, pacemaker, cardioverter defibrillators implantable, mechanical heart valve non MRI-compatible) Weight> 130 kg Pregnant, parturient or breastfeeding Persons deprived of their liberty by a judicial or administrative decision, Adults subject to a legal protection measure (safeguard measure, guardianship, curators) subject participating in another research including an exclusion period still in progress at inclusion For recipients : - Contraindication to renal graft biopsy (ongoing or uninterrupted anticoagulant or antiplatelet treatment, thrombocytopenia <100 x 10^9/L, anemia <7 g/dL).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Living kidney donor

    Recipient of kidney transplant from living donor

    Arm Description

    Patient eligible for living kidney donation with eGFR > 60 ml/min/1.73m²

    Patient with end-stage chronic kidney failure awaiting kidney transplant from living donor

    Outcomes

    Primary Outcome Measures

    Apparent diffusion coefficient (ADC) coefficient values measured in diffusion-weighted MRI sequence

    Secondary Outcome Measures

    In recipients, R2* values measured by BOLD MRI
    In recipients, T2 Values measured by T2 mapping MRI
    In recipients, T1 Values measured by T1 mapping MRI

    Full Information

    First Posted
    September 14, 2023
    Last Updated
    September 20, 2023
    Sponsor
    Hospices Civils de Lyon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06047106
    Brief Title
    Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation.
    Acronym
    DOVIMIR
    Official Title
    DOVIMIR : Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    March 2027 (Anticipated)
    Study Completion Date
    March 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospices Civils de Lyon

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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. GFR 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. Kidney grafts from older living donors maintain better renal function than those from deceased donors, aiming to counteract the organ shortage. Kidneys 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. The 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. Therefore, 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. Hence, 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Insufficiency, Chronic
    Keywords
    Living Donor Donation, multiparametric MRI, ischemia reperfusion injury, kidney graft

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Monocentric, Prospective, Non-randomized, Exploratory Study
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Living kidney donor
    Arm Type
    Experimental
    Arm Description
    Patient eligible for living kidney donation with eGFR > 60 ml/min/1.73m²
    Arm Title
    Recipient of kidney transplant from living donor
    Arm Type
    Experimental
    Arm Description
    Patient with end-stage chronic kidney failure awaiting kidney transplant from living donor
    Intervention Type
    Radiation
    Intervention Name(s)
    multiparametric MRI
    Intervention 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. For 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    kidney graft biopsy
    Intervention Description
    Biopsy of the graft itself prior to transplantation in the recipient.
    Intervention Type
    Biological
    Intervention Name(s)
    blood samples
    Intervention Description
    For donors who are not selected to donate their kidney, a total of 2 mL of blood will be collected at inclusion. For donors eligible to donate, a total of 4 mL of blood will be collected (at inclusion and at 12 months post-transplant). For recipients, a total of 26 mL of blood will be collected (pre-transplant, 1 month and 12 months post-transplant).
    Intervention Type
    Biological
    Intervention Name(s)
    urine specimens
    Intervention Description
    For donors who are not selected to donate their kidney, a total of 15 mL of urine will be collected at inclusion. For donors eligible to donate, a total of 50 mL of urine will be collected (at inclusion and at 12 months post-transplant). For recipients, a total of 65 mL of urine will be collected (pre-transplant, 1 month and 12 months post-transplant).
    Primary Outcome Measure Information:
    Title
    Apparent diffusion coefficient (ADC) coefficient values measured in diffusion-weighted MRI sequence
    Time Frame
    Baseline before transplantation, one month and 12 months after kidney transplantation
    Secondary Outcome Measure Information:
    Title
    In recipients, R2* values measured by BOLD MRI
    Time Frame
    Baseline before transplantation, one month and 12 months after kidney transplantation
    Title
    In recipients, T2 Values measured by T2 mapping MRI
    Time Frame
    Baseline before transplantation, one month and 12 months after kidney transplantation
    Title
    In recipients, T1 Values measured by T1 mapping MRI
    Time Frame
    Baseline before transplantation, one month and 12 months after kidney transplantation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: For recipients: Patients with end-stage chronic kidney disease awaiting kidney transplant from a living donor. Adult patient Consent signed effective contraceptive method for women Patient affiliated to a social security or beneficiaries of a similar scheme For donors: Individuals eligible for living kidney donation with GFR > 60 mL/min/1.73 m². Adult patient Consent signed effective contraceptive method for women Patient affiliated to a social security or beneficiaries of a similar scheme Exclusion Criteria: For the two groups : MRI contraindications (claustrophobia, pacemaker, cardioverter defibrillators implantable, mechanical heart valve non MRI-compatible) Weight> 130 kg Pregnant, parturient or breastfeeding Persons deprived of their liberty by a judicial or administrative decision, Adults subject to a legal protection measure (safeguard measure, guardianship, curators) subject participating in another research including an exclusion period still in progress at inclusion For recipients : - Contraindication to renal graft biopsy (ongoing or uninterrupted anticoagulant or antiplatelet treatment, thrombocytopenia <100 x 10^9/L, anemia <7 g/dL).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sandrine LEMOINE, PU-PH
    Phone
    04 72 11 02 44
    Email
    sandrine.lemoine01@chu-lyon.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marine GIRERD
    Phone
    04 72 11 06 20
    Email
    marine.girerd@chu-lyon.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sandrine LEMOINE, PU-PH
    Organizational Affiliation
    Service de néphrologie à l'Hôpital Edouard Herriot
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation.

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