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

June 5, 2026 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69003
        • Recruiting
        • Hôpital Edouard Herriot, Hospices Civils de Lyon
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Living kidney donor
Patient eligible for living kidney donation with eGFR > 60 ml/min/1.73m²
Radiation: multiparametric MRI

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.

Biological: urine specimens

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).

Biological: blood samples

For donors who are not selected to donate their kidney, a total of 4 mL of blood will be collected at inclusion.

For donors eligible to donate, a total of 8 mL of blood will be collected (at inclusion and at 12 months post-transplant).

For recipients, a total of 32 mL of blood will be collected (pre-transplant, 1 month and 12 months post-transplant).
Experimental: Recipient of kidney transplant from living donor
Patient with end-stage chronic kidney failure awaiting kidney transplant from living donor
Radiation: multiparametric MRI

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.

Biological: urine specimens

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).

Procedure: kidney graft biopsy
Biopsy of the graft itself prior to transplantation in the recipient.
Biological: blood samples

For donors who are not selected to donate their kidney, a total of 4 mL of blood will be collected at inclusion.

For donors eligible to donate, a total of 8 mL of blood will be collected (at inclusion and at 12 months post-transplant).

For recipients, a total of 32 mL of blood will be collected (pre-transplant, 1 month and 12 months post-transplant).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline before transplantation, one month and 12 months after kidney transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
In recipients, R2* values measured by BOLD MRI
Time Frame: Baseline before transplantation, one month and 12 months after kidney transplantation
Baseline before transplantation, one month and 12 months after kidney transplantation
In recipients, T2 Values measured by T2 mapping MRI
Time Frame: Baseline before transplantation, one month and 12 months after kidney transplantation
Baseline before transplantation, one month and 12 months after kidney transplantation
In recipients, T1 Values measured by T1 mapping MRI
Time Frame: Baseline before transplantation, one month and 12 months after kidney transplantation
Baseline before transplantation, one month and 12 months after kidney transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sandrine LEMOINE, PU-PH, Service de néphrologie à l'Hôpital Edouard Herriot

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2024

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL23_0324
  • 2023-A01402-43 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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